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Part II - Full Texts of Selected Investigations

Case No. E.289/98-99 - Consultants' failure to identify bowel cancer

Complaint against: Southport & Ormskirk Hospital NHS Trust (formerly West Lancashire NHS Trust)

Complaint as put by Mrs V

1. The account of the complaint provided by Mrs V was that her GP referred her to the accident and emergency department of the Ormskirk and District General Hospital (the hospital) on 14 April 1997 suffering from severe anaemia, diarrhoea, weight loss and pain in her lower abdomen. She was admitted and given a blood transfusion. Mrs V was examined by a consultant surgeon (the consultant surgeon) and a gastroscopy (an inspection of the interior of the stomach) was performed by a gastroenterologist which showed a hiatus hernia (a protrusion of part of the stomach through the diaphragm). A barium enema (injection of the contrast agent barium for radiological examination) showed diverticulitis (inflammation of the large bowel). An ultrasound test was reported as normal. Mrs V was discharged from hospital on 24 April. A colonoscopy (visualisation of the large bowel) carried out in July 1997 confirmed the diagnosis of diverticulitis. On 1 September, Mrs V was seen again by the consultant surgeon who prescribed iron tablets and planned to review her again in two months.

2. On 1 October, while on holiday abroad, Mrs V was admitted to hospital. When she was examined, a mass (swelling) was felt in her lower abdomen. A CT (computed tomography—computer constructed imaging technique) scan was followed by surgery to remove a cancerous mass measuring 11 x 9cm from her caecum (the first part of the large bowel). On 17 October, Mrs V complained to the chief executive of the West Lancashire NHS Trust (the former Trust), which, then, managed the hospital. Mrs V remained dissatisfied with the Trust's response and, on 16 November, requested an independent review of her complaint. The convener wrote to Mrs V on 15 April 1998 refusing her request.

3. The matter investigated was that the medical staff involved in Mrs V's care failed to diagnose her condition and that this resulted in delay in treating her bowel cancer.

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Investigation

4. The statement of complaint for the investigation was issued on 24 August 1998. The Trust's comments were obtained and relevant papers and radiographs were examined. One of the Ombudsman's investigators interviewed Mrs V, the consultant surgeon, the consultant radiologist and the gastroenterologist. Independent radiological advice was sought on Mrs V's barium enema films and an extract from this is reproduced at paragraph 12 of this report. Two independent professional assessors were appointed to advise on the clinical issues in this case and their findings are summarised at paragraphs 13 and 14 and are reproduced in full at Annex A. Medical terms are explained in the text where they first appear, supplemented by a glossary at Annex B.

Mrs V's evidence

5. Mrs V said when interviewed by the Ombudsman's investigator that in January 1997 she complained to her GP of diarrhoea, pain, tiredness and weight loss. In April that year, her GP requested a blood test which showed her to be anaemic. Mrs V was referred to the hospital's accident and emergency department on 14 April and she was admitted at once. Mrs V was given a blood transfusion and a gastroscopy was performed which showed hiatus hernia. Mrs V told the consultant surgeon about her diarrhoea, pain and weight loss. He arranged for a barium enema which revealed diverticulitis. An ultrasound scan proved negative. Mrs V saw the senior house officer (the SHO) to the consultant surgeon in the outpatients department on 5 May. She told him that her bowel habits had initially returned to normal following the barium enema; but that the diarrhoea had started to return and that she continued to feel tired. The SHO arranged for a colonoscopy. In a letter to the Trust dated 17 October 1997, Mrs V explained that she delayed having the colonoscopy until 29 July because she believed that she would be unable to tolerate the bowel preparation. She was seen and examined by the SHO on 15 August.

6. Both the consultant surgeon and his SHO saw Mrs V on 1 September. The clinic was running late; the consultation was very rushed and she was not examined. She told the consultant surgeon that, although she felt better than in April, she was 'still not right'. Mrs V was told that she would be seen again in two months and that she should obtain a prescription for iron tablets from her GP. Mrs V was disappointed with the consultation. She went on holiday soon afterwards, became ill and was admitted to hospital while abroad.

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The Trust's response to the complaint

7. In his formal response to the Ombudsman at the beginning of this investigation the chief executive wrote:

'During and following Mrs V's admission to this hospital the cause of the symptoms she presented with were, by a process of elimination, being investigated. The outcome of the investigations up to and including the 1 September 1997 did not reveal the presence of an abdominal tumour. [The consultant surgeon] had not discharged Mrs V from his care and was due to see her again in the Out-patients Department on 3 November 1997.

'The medical staff had taken the action that they considered appropriate to identify the cause of Mrs V's symptoms. In view of the outcome of all the investigations carried out, I consider that had the tumour been evident I am certain that it would have been identified by the Consultants involved.'

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Evidence of Trust staff

8. The consultant surgeon said, when interviewed by the Ombudsman's investigator, that when he saw Mrs V on 19 April she complained of weight loss, diarrhoea and anaemia. He examined her and found that she was tender in the right iliac fossa (the lower right abdomen). He also believed that he may have felt a mass in her abdomen. He suspected cancer of the caecum at that time. He did not always view barium enema films reported to him and could not recall whether he had done so in this case; but he knew that they showed diverticular disease. He would have accepted the consultant radiologist's report with confidence. He did not discuss Mrs V's colonoscopy with the gastroenterologist, who was a respected colleague. The consultant surgeon said that some of the delay in progressing Mrs V's investigations resulted from factors outside his control. Generally the delays that occurred were reasonable within the context of his working regime.

9. On 1 September, the consultant surgeon continued to suspect carcinoma as the cause of Mrs V's condition. He did not accept that her anaemia was the result of diverticulitis or a hiatus hernia. However, he was satisfied with the reports of the investigations carried out by his colleagues as a result of which he believed carcinoma of the caecum to have been eliminated. He had been "put off the scent" because these investigations suggested that his initial clinical suspicions were unfounded. He did not recall examining Mrs V on 1 September. With hindsight, he thought it possible that, if he had palpated Mrs V's abdomen that day, he would have felt the mass. He had planned to see her again as he had not completed his investigations.

10. The consultant radiologist studied the films of Mrs V's barium enema in the presence of one of the Ombudsman's clinical assessors. He believed the caecum to be clearly visible and that he would have palpated (felt with hands and fingertips) under screen control (continued visualisation). He agreed that something could be seen at the proximal transverse colon (the portion of the colon that runs across the upper part of the abdomen) on the inferior (lower) border. He assumed that he would have palpated the area with his glove at the time and concluded it to be faecal residue (waste matter). He had not considered repeating the procedure because he had had no concerns that the level of faecal residue prevented accurate radiological assessment. The consultant radiologist said that the majority of his colleagues would accept the reports of his findings, though he had, on occasion, tried to persuade them to examine the films as well as his reports. He accepted that investigation by barium enema was not an infallible procedure.

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11. The gastroenterologist said that he saw the letter referring Mrs V for colonoscopy on 19 May and expected that she would be seen within a month. However when a patient was not well enough to undergo the procedure, as in this case, he would 're-book' them as a matter of urgency. He explained his colonoscopy procedure to the Ombudsman's clinical assessor. He said that Mrs V had diverticular disease and her examination would have been lengthy. He was aware that the 'scope' should reach the caecum and believed that it did so in 90% of his cases. He believed that he had reached Mrs V's caecum and found it to be normal.

Independent clinical advice

Radiological report

12. I sought independent radiological opinion on the barium enema films taken on 21 April 1997. This independent assessor is critical of the technical adequacy of the films and that too much barium remained in the colon when they were taken. His report contains the following findings.

'Three of the spot images [films taken of specific sections of the bowel] demonstrate an abnormality in the mid transverse colon with destruction of the mucosal line and an intraluminal filling defect consistent with malignancy. The lateral decubitus films [taken with the patient on her side) showing both sides of the caecum and the ascending colon show filling defects within the caecum and a suggestion of deformity of the lateral margin of the ascending colon. However as previously noted the excess barium obscures detail and this area is not adequately demonstrated on the spot images. With careful attention to technique and patient positioning it is usually possible to open out the splenic and hepatic flexure.

The technique employed in this examination is suboptimal. Insufficient attention has been paid to adequate coating of the bowel. The filming technique does not ensure that all areas are demonstrated in two projections and with adequate double contrast. Insufficient effort seems to have been made to compensate for the above deficiencies.

As barium enema examination is one of the highest dose techniques carried out and involves rather unpleasant bowel preparation prior to the procedure I think we have a duty to pay meticulous attention to the way the examination is carried out and interpreted. Although we all come across difficult patients I can see no evidence on these images that lack of patient co-operation was a limiting factor.'

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Independent professional assessors' report

13. The independent assessors appointed to advise on the clinical issues in this case conducted a very thorough review of the documentary evidence and one of the assessors interviewed the consultant staff involved. The assessors' report is reproduced in full as Appendix A to this report and is summarised here. They addressed the following key questions:

1. Was the management of Mrs V's case appropriate in the light of her symptoms and signs on presentation in April 1997?

2. Were the investigations chosen to establish the diagnosis appropriate?

3. Was the timescale of investigations unnecessarily prolonged?

4. Were the barium enema and the colonoscopy adequately performed, interpreted and reported?

5. Should other or repeat investigations have been performed when the standard investigations did not reveal the clinically suspected cancer?

6. Should the medical staff have had a higher index of suspicion of an underlying cancer and been more rigorous in their search for the cause of Mrs V's unexplained anaemia?

7. Is it likely that the cancer could have been felt on 1 September 1997 if Mrs V had been examined?

8. If the diagnosis had been made on or immediately after 1 September 1997 would it have altered the outcome?

9. Did Mrs V's overall care fall short of acceptable standards?

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14. The assessors discuss these matters in their report and conclude that three factors contributed to the delay in diagnosing Mrs V's caecal carcinoma:

(i) Radiological failure: failure of the barium enema to demonstrate the carcinoma. The assessors concluded that, had the consultant radiologist's technique been better, Mrs V's cancer might have been diagnosed in April 1997.

(ii) Endoscopic failure: failure of the colonoscopy to visualise the caecum and demonstrate the carcinoma. The assessors conclude that had the gastroenterologist's report indicated that the colonoscopy had not ruled out a diagnosis of carcinoma of the caecum, the consultant surgeon's actions and decisions on 1 September might have been different.

(iii) Clinical failure: failure to examine Mrs V when she attended the outpatient clinic on 1 September 1997. The assessors conclude that the consultant surgeon should have been aware of the limitations of the diagnostic investigations which had been undertaken and, based on his knowledge of Mrs V's anaemia at presentation in April and his clinical impression of a mass in the right lower abdomen at that time, he should have re-examined her.

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Overall, the assessors conclude that the care given to Mrs V was 'less than ideal'.

Findings

15. Mrs V was suffering from severe anaemia in April 1997. Initial consideration of her condition by the consultant surgeon led him to suspect the cause to be cancer of the caecum. He arranged for the appropriate investigations to be carried out—gastroscopy, barium enema and colonoscopy—to confirm his diagnosis. I am persuaded by the clinical assessors in this case and the independent radiological advice I obtained, that the technique of the barium enema carried out by the consultant radiologist was suboptimal. However, he interpreted it as normal and reported accordingly. Had he reported any cause for concern the next appropriate investigation would have been a colonoscopy which, in the event, was carried out. The gastroenterologist who did so said, when interviewed, that he reached the caecum in 90% of cases and did so with Mrs V. The assessors consider the achievement of this degree of accuracy in a difficult procedure unlikely and I accept that advice. The consultant radiologist and gastroenterologist failed to perform and interpret their procedures adequately. This led to Mrs V's condition remaining undiagnosed and there was, as a consequence, an avoidable delay in treating her bowel cancer. The consultant surgeon did not question the reports of his experienced colleagues. He has said that he was 'put off the scent' by their over-confident reporting and the clinical assessors have expressed the view that he gave insufficient weight to the limitations of the investigations carried out. As a result the consultant surgeon ruled out his initial suspicion that Mrs V was suffering from cancer of the caecum, though he has said that he continued to suspect carcinoma as the cause of her condition.

16. I accept, of course, that procedures such as barium enema and colonoscopy are likely to prove inconclusive in a significant proportion of cases. However, I agree with the clinical assessors that the clinicians in this case should have pursued their search for the cause of Mrs V's anaemia with greater rigour. If the consultant surgeon had examined her when he saw her on 1 September, it is very likely that he would have felt the mass in her abdomen and surgery could have been performed two weeks earlier than was the case. At the very least, Mrs V would have been spared the distress of becoming ill and requiring surgery while on holiday abroad. I conclude that the care given to Mrs V was less than adequate. I uphold the complaint.

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17. My findings in this case and the assessors' opinion lead me to make the following observations. It seems clear that the reports of specialist diagnostic procedures should include some indication of their limitations—for example, the possibility that the procedure was not completed. I also consider, as do the assessors, that it would be good practice for clinicians commissioning investigatory work to discuss their concerns with the specialist concerned—in this case with the consultant radiologist and consultant gastroenterologist. Should the outcome of the investigation not support a firm clinical diagnosis and where there is a suspicion of a serious condition such as cancer, a patient should always be re-examined.

18. I have also considered, in the light of advice from the clinical assessors, the reasonableness of the timescale between Mrs V's discharge from hospital on 24 April and the completion of further investigations by the end of August, a period of over four months. The assessors comment that at first sight there seems to have been undue delay. However, they point out, rightly, that some of this can be accounted for by Mrs V, not unreasonably, having cancelled her appointment for colonoscopy on 20 June. The assessors comment that the remainder of the delay which occurred was compatible with NHS performance and, in view of the hard pressed nature of the service, not unduly long.

Conclusions

19. I have set out my findings in paragraph 15-18. The Trust has agreed to consider with the clinicians involved, the observations I make in paragraph 17 and has asked me to convey to Mrs V—as I do through this report—its apology for the shortcomings I have identified. Back to top

Annex A

Professional Assessors' Report

"The matter subject to investigation is that the medical staff involved in Mrs V's care failed to diagnose her condition resulting in a delay in her treatment for bowel cancer."

1. This report has been compiled from four sources.

(i) The Hospital notes from Ormskirk and District General Hospital, including correspondence from the relevant clinicians as part of the Trust's initial response to the complaint, and a barium enema x-ray examination carried out on 21 April 1997.

(ii) A translated report from the hospital in Spain where Mrs V was treated, and a CT scan and contrast x-rays carried out in Spain in October 1997.

(iii) Personal interviews by one assessor with the Consultant Radiologist, SHO and Gastroenterologist, and the Consultant Surgeon, all of Ormskirk and District General Hospital on Tuesday 3 November 1998.

(iv) Transcript of an interview carried out by the Ombudsman's investigator with the complainant on 18 September 1998.

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The Facts

2. Mrs V was referred by her general practitioner to the consultant surgeon at Ormskirk and District General Hospital with a letter dated 6 March 1997. Her complaints were of diarrhoea and weight loss and her general practitioner had found an area of tenderness in the lower right side of her abdomen. Her letter was reviewed on 17 March 1997 and she was designated 'soon' (as opposed to urgent or routine) and sent an out-patient appointment for 18 April 1997. She was subsequently referred for an emergency admission on 14 April 1997 by her general practitioner after a blood test revealed a haemoglobin of 7.8 g/dl indicating that she was severely anaemic. She was admitted to Ormskirk and District General Hospital under the care of a consultant physician. Her weight on admission was 12st. 8lbs. She received a two unit blood transfusion and was investigated to establish the cause of her iron deficiency anaemia. At the time of admission her symptoms are recorded as diarrhoea, weight loss, anaemia, tiredness and weakness. Abdominal examination is recorded as normal. A gastroscopy was performed on 18 April 1997 and revealed a small hiatus hernia but no source of chronic blood loss within the oesophagus, stomach, or duodenum [first part of the small intestine]. She was referred to the consultant surgeon for a surgical opinion and he saw her on the ward on 19 April 1997. His comment in the notes is 'She is tender with ?mass in right iliac fossa ?Ca caecum'. A barium enema was ordered and carried out on 21 April 1997 by the consultant radiologist. The report reads 'Barium passes without obstruction to the caecum. Diverticular disease in the pelvic colon but no other abnormality shown in the large bowel'. Her stool was tested for occult blood [small quantities not visible to the naked eye] and was positive in two out of three specimens. She underwent an abdominal ultrasound scan on 24 April 1997 which was reported 'Entirely normal examination with no visible abnormality in the abdomen'. She was discharged on 25 April 1997 with an out-patient appointment for the consultant surgeon's clinic on 2 May 1997. Her haemoglobin level at discharge was 11.9 g/dl.

3. On 2 May 1997 she attended the consultant surgeon's out-patient clinic where she was seen by the SHO. She reported that she was feeling better and that she had normal bowel actions after the barium enema, but that her previous symptoms of diarrhoea were beginning to return. She was referred to a gastroenterologist (the gastroenterologist) for a colonoscopy with a request for 'An early appointment'. Her haemoglobin was 11.2 g/dl. The referral letter was acknowledged by the gastroenterologist on 19 May 1997 and she was given an appointment for a colonoscopy on 20 June 1997. The laxative she was given as preparation for her colonoscopy made her sick and she telephoned the hospital and cancelled the appointment. The colonoscopy was rescheduled for 29 July 1997. She attended on 29 July when a colonoscopy was performed by the gastroenterologist. The report of the procedure records diverticular disease in the sigmoid colon [lower end of the last part of the large intestine] and that the remainder of the bowel, including the caecum, was normal. An out-patient appointment was made for the consultant surgeon's clinic on 15 August 1997.

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4. When she attended the consultant surgeon's out-patient clinic on 15 August 1997, the consultant surgeon was away and she was seen by the SHO. She complained of feeling tired. Her weight was recorded as 12st. 7.5lbs. The SHO records in his letter to the general practitioner 'Her abdominal examination was unremarkable'. Her haemoglobin was checked and recorded as 10.7 g/dl and she had not taken any iron supplements since discharge in April. A further appointment was made for her to see the consultant surgeon in two weeks time. She attended the out-patient clinic on 1 September 1997 and saw the consultant surgeon. There are no hospital notes for this consultation, but there is a letter to the general practitioner. She was not examined. She was put on iron tablets and given a review appointment for two months time.

5. On 1 October 1997, she was admitted to hospital in Spain as an emergency. On 3 October 1997, she underwent an operation for a right hemicolectomy to remove a cancerous growth involving the caecum and ascending colon. The cancerous growth had been measured at 11 x 9 cm on a CT scan carried out the day before surgery.

6. Mrs V made a satisfactory recovery from her operation and has subsequently undergone a course of chemotherapy.

7. Despite being admitted to hospital on 14 April 1997 with symptoms and signs compatible with a cancer arising in the right side of the bowel, Mrs V's was not diagnosed until her operation in Spain on 3 October 1997, five months later. The following questions need to be answered.

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8. Questions

(i) Was the management of Mrs V's case appropriate in the light of her symptoms and signs on presentation in April 1997?

(ii) Were the investigations chosen to establish the diagnosis appropriate?

(iii) Was the timescale of her investigations unnecessarily prolonged?

(iv) Were the barium enema and the colonoscopy adequately performed, interpreted and reported?

(v) Should other or repeat investigations have been performed when the standard investigations did not reveal the clinically suspected cancer?

(iv) Should the medical staff have had a higher index of suspicion of an underlying cancer and been more rigourous in their search for the cause of her unexplained anaemia?

(vii) Is it likely that the cancer could have been felt on 1 September 1997 if she had been examined?

(viii) If the diagnosis had been made on or immediately after 1 September 1997 would it have altered the outcome?

(ix) Did her overall care fall short of acceptable standards?

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9. Discussion of the issues

(i) Was the management of Mrs V's case appropriate in the light of her symptoms and signs of presentation in April 1997?

When found to be severely anaemic she was correctly admitted immediately to hospital and transfused to restore her haemoglobin level to the normal range. Iron deficiency anaemia is commonly caused by chronic, undetected blood loss from the stomach or bowel. The most likely cause would be a polyp or cancer in the bowel, or an ulcer or cancer in the stomach. Hiatus hernia and diverticular disease are uncommon causes of chronic anaemia. The appropriate investigations would be a gastroscopy and barium enema, both of which were performed during her admission and reported as normal. The normal findings on ultrasound scan do not exclude any of the common causes of anaemia. A CT scan would not have been appropriate at this stage. Despite the normal gastroscopy and barium enema the most likely explanation of her anaemia was a cancer or polyp in the bowel, undetected by the barium enema, and a colonoscopy was the appropriate next investigation. This was arranged and took place on 29 July 1997; it was reported as normal. Following this investigation she was reviewed in the consultant surgeon's out-patient clinic.

There is a discrepancy between Mrs V's record of her symptoms and those recorded in the hospital notes. She records continuing diarrhoea, abdominal pain and weight loss. In May, she admitted to being better and having normal bowel actions following her barium enema, but did mention that her original symptoms were recurring. In August and September her symptoms recorded in the notes were of tiredness, and not pain or diarrhoea. Her weight had remained unchanged from April to August, and her haemoglobin had fallen only minimally from 11.9 g/dl at discharge on 25 April 1997 to 10.7 g/dl on 15 August 1997 and she had not received any iron supplements. In the light of her symptoms, and the negative results of her barium enema and colonoscopy, her management up to 1 September was appropriate.

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(ii) Were the investigations chosen to establish the diagnosis appropriate?

The investigations used were gastroscopy, barium enema, abdominal ultrasound scan, and colonoscopy. These investigations were entirely appropriate to her symptoms and signs. Prior to 1 September there was no indication for other investigations, including a CT scan.

(iii) Was the timescale of her investigations unnecessarily prolonged?

At first sight, there appears to have been undue delay, in that following discharge from hospital on 24 April 1997, having been treated for iron deficiency anaemia and the possibility of a mass in her right lower abdomen, it was four months before the investigations were completed and she was seen by the consultant surgeon in the out-patient clinic. However, all the investigations had been reported as normal. When scrutinised it is apparent that, despite the length of the cumulative delay, the individual delays were all compatible with normal NHS practice. Following discharge in April Mrs V was reviewed in the out-patient clinic in two weeks. A colonoscopy was requested by written referral to the gastroenterologist who provided the local diagnostic colonoscopy service. It was requested that she have an 'Early appointment'. The letter was acknowledged by the gastroenterologist two weeks later and an appointment made for a colonoscopy within four weeks. The gastroenterologist has stated that he receives between thirty and forty requests for colonoscopy examinations each week, but has only ten available spaces per week for the investigations. Many patients in Ormskirk and District General Hospital waited four or more months, and when the waiting lists reached significant proportions the backlog was usually cleared by a Health Authority financial initiative. The wait of one month was not unacceptable bearing in mind that the barium enema had been reported as normal and Mrs V cancelled her appointment for 20 June 1997 because the medication for necessary preparation of the bowel for colonoscopy made her vomit. The examination was rescheduled for 29 July 1997. In the light of the hard-pressed nature of the service this timescale is not unduly long. Following the colonoscopy on 29 July 1997 she had an out-patient appointment to see the referring surgeon, the consultant surgeon, in two weeks, on 15 August 1997. On that day she was seen by the SHO, as the consultant surgeon was away. A further out-patient appointment was scheduled for 1 September 1997 when she saw the consultant surgeon.

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On the basis of the available information detailed here we consider the four month delay between discharge from hospital and an appointment with the consultant with the completed investigations to be long, but compatible with current constraints within the NHS. As the barium enema and colonoscopy were reported as normal there was no indication to 'fast track' Mrs V at any stage. We do not consider there to have been a failure by either the Trust or the clinicians to provide an adequate service in terms of the time taken for these procedures.

(iv) Were the barium enema and the colonoscopy adequately performed, interpreted and reported?

This question was considered in personal interviews between one assessor and the consultant radiologist who performed the barium enema, and the gastroenterologist who performed the colonoscopy. The consultant radiologist works in a department of five radiologists. He has considerable experience in contrast radiology (barium enema) of the bowel. Mrs V's barium enema was performed while she was still in hospital. Many trusts are unable to provide such a speedy service for complex investigations such as barium enema and Mrs V benefited from the efficient service at Ormskirk and District General Hospital. The consultant radiologist explained that the radiology department tried to do all in-patient xray procedures as soon as possible while the patient was still in hospital, with the consequence that out-patients often waited up to thirty weeks for a barium enema.

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The consultant radiologist described his technique for barium enema which used screening (the continual visualisation of barium as it is run into the bowel), spot films (films taken of specific sections of the bowel which may be poorly seen on screening or where there is doubt about an area during the screening) and lateral decubitus films to show both sides of the caecum and ascending colon. The films were discussed in detail with the consultant radiologist; he felt that the irregularities noted on the films were due to faeces [waste matter] on the bowel wall and had they been due to a growth this would have been apparent during the screening phase of the examination. The consultant radiologist said he tended to write short reports; if he felt an investigation was normal he would say so and that he felt it appropriate that with his experience and skill he should give a firm opinion. A barium enema cannot be accurately assessed from the static films; the interpretation is dependant upon what is seen during screening, of which recordings are not kept. The consultant radiologist carried out a barium enema which he interpreted as normal and reported accordingly. Had there been doubt about any area of bowel seen on barium enema the appropriate next investigation would be a colonoscopy, which was requested despite the normal report on the barium enema.

The gastroenterologist is a consultant physician with a special interest in gastroenterology. He trained as a gastroenterologist in Edinburgh before working for ten years in Zimbabwe as a senior lecturer and then professor of medicine. He provides the colonoscopy service to a population of approximately 250,000 people. He receives between thirty and forty requests per week from general practitioners and from consultant colleagues. He has two sessions per week devoted to endoscopy and does five colonoscopies in each session. He views his role usually as that of a technician providing a diagnostic service. He does not undertake a consultation or formal examination or offer an opinion, unless specifically requested. He undertakes a colonoscopy, and reports his findings to the referring clinician for the latter to interpret and use as appropriate.

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In Ormskirk the routine wait for a colonoscopy is four to six months. Urgent requests are usually dealt with in two weeks, but often at the expense of cancelling an already booked patient. The gastroenterologist described his technique. He does about ninety-nine per cent of the procedures himself. Intravenous sedation and intravenous pain-killers are used. He uses an assistant to introduce the instrument while he manipulates the controls and watches the video screen. His assistant also applies pressure in the abdomen to aid the passage of the instrument. The gastroenterologist claims to reach the caecum, the proximal end of the bowel and the limit of the investigation, and the site of Mrs V's cancer, in ninety per cent of cases. This level of successful intubation to the caecum is compatible with a high degree of expertise. The gastroenterologist stated that he always knew when he had reached the caecum and when he had not.

It is well known that the caecum can be notoriously difficult to recognise and that there is no simple test to indicate if and when the instrument reaches the caecum. The assessors think it unlikely that the colonoscope reached the caecum in Mrs V's case, despite the gastroenterologist's confident report that it did so. The report did not allow for the possibility that the caecum was not reached and inspected. Those ordering colonoscopic examinations are not always aware of the difficulties and limitations of the investigation. The confident report of a normal caecum, both on barium enema and on colonoscopy, influenced the consultant surgeon's subsequent actions.

The barium enema has been separately reviewed by an expert radiologist who considered the technique employed to have been suboptimal. The assessors considered the barium enema films to be worrying as regards the caecum, the area about which there was clinical concern, and the transverse colon. Many surgeons review barium enema films themselves and, if concerned, discuss the films further with the radiologist. The consultant surgeon stated that he did not usually do this and was happy to accept the report of the consultant radiologist, an experienced colleague who he trusted. If the consultant surgeon or his SHO had expressed concerns about the barium enema the appropriate action would have been to proceed to colonoscopy. This was, in fact, done despite the normal barium enema report. The assessors considered the barium enema to have been suboptimal in its performance and interpretation and to have been over-confidently reported as normal. Similarly, the colonoscopy report did not acknowledge the limitations of the technique and the assessors feel that the gastroenterologist did not pass the instrument to the caecum, despite his confident report that he did so and that it was normal. The assessors, whilst recognising the limitations of both barium enema and colonoscopy, considered the investigations to have been suboptimally performed and over-confidently reported. However, only the firm diagnosis of a cancer in the caecum on the barium enema of 21 April 1997 would have altered the subsequent timescale of events.

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(v) Should other or repeat investigation have been performed when the standard investigations did not reveal the clinically suspected cancer?

When Mrs V was seen by the consultant surgeon on 1 September 1997 she had undergone standard investigations for anaemia, gastroscopy, barium enema and colonoscopy, and all had been reported as normal by trusted and respected colleagues. Her symptoms were not recorded as significantly worse, her weight had not fallen and her haemoglobin was minimally reduced, all of which led the consultant surgeon to feel that although the cause of the original anaemia had not been established serious causes, including carcinoma of the caecum, were ruled out. Repeating the same investigations at that time, in the light of the reports received, would not have been appropriate. The consultant surgeon admits that he was unsure what to do next, but felt that it was reasonable to review Mrs V in two months time. The development of further symptoms over that time may then have indicated the appropriate direction for further investigations. The assessors feel that the consultant surgeon should have considered other conditions at this time.

(vi) Should the medical staff have had a higher index of suspicion of an underlying cancer and been more rigourous in their search for the cause of her unexplained anaemia?

The clinicians initially had a high level of suspicion of a carcinoma of the caecum, but with subsequent investigations appearing to exclude the diagnosis the index of suspicion naturally fell. This was supported by the apparent improvement clinically, the lack of weight loss, and the very minimal reduction in haemoglobin over four months. However, the assessors feel that on 1 September 1997 Mrs V should have been fully examined by the consultant surgeon and further investigations should have been pursued, as the cause of Mrs V's initial profound anaemia had not been established nor the original clinical signs explained.

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(vii) Is it likely that the cancer could have been felt on 1 September 1997 if she had been examined?

The assessors are of the view that had the consultant surgeon examined Mrs Vs' abdomen on 1 September 1997 the mass in the right iliac fossa would have been palpable. The consultant surgeon did not examine her on that day. She was seen at the end of a very busy clinic, some hour after her appointed time, and the consultant surgeon was aware that the SHO, an experienced SHO, had examined her abdomen two weeks before and not felt a mass.

(viii) If the diagnosis had been made on or immediately after 1 September 1997 would it have altered the outcome?

Had a mass been found on 1 September 1997 it is probable that Mrs V would have been admitted to hospital for urgent surgery, in which case her operation would probably have taken place about two weeks before it actually did. The outcome would not have been different, but Mrs V would have been spared the distress of becoming ill and requiring major surgery while in a foreign country.

(ix) Did her overall care fall short of acceptable standards?

Mrs V presented in April 1997 with symptoms and signs that suggested a carcinoma of the caecum. Despite undergoing standard investigations a diagnosis was not established until five months later when she underwent emergency surgery while on holiday in Spain. The investigations undertaken were appropriate. The timescale over which they and subsequent out-patient follow up were undertaken was prolonged and this was due to a delay of two and a half months between referral for colonoscopy and its performance. In the knowledge of the pressures on the colonoscopy service in Ormskirk, and the fact that the first colonoscopy appointment was cancelled by Mrs V and this procedure had to be rescheduled, the delay is explicable and within a range common within the NHS.

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10. Conclusions

10.1 It is the assessors' view that three factors contributed to the delay in the diagnosis of Mrs V's caecal carcinoma.

1. Radiological failure: Failure of the barium enema to demonstrate the carcinoma.

2. Endoscopic failure: Failure of colonoscopy to visualise the caecum and demonstrate the carcinoma.

3. Clinical failure: Failure to re-examine Mrs V in the outpatient clinic.

10.2 A barium enema may fail to demonstrate a carcinoma of the caecum in about 20% of cases. This is due to a combination of inherent weaknesses of the investigation, however well it is performed, poor technique by the radiologist carrying out the procedure, and the stage of the disease and the size of the cancer when the investigation is performed. The assessors consider the barium enema films demonstrated worrying irregularities in the caecum. Expert radiological opinion considered the consultant radiologist technique to have been suboptimal. Had the consultant radiologist's technique been better the cancer may have been diagnosed in April 1997.

10.3 Colonoscopy fails to visualise the caecum in a significant proportion of cases. This may be due to the colonoscopist's experience and technique, the length and configuration of the colon and the presence of co-existing conditions such as diverticular disease. Mrs V had diverticular disease in the sigmoid colon and the gastroenterologist recorded that the colonoscopy was difficult. Nevertheless, he categorically reported the caecum as normal. The methods used to verify that the caecum has been reached are notoriously inaccurate. The only way that the colonoscopist can confirm that the caecum has been visualised is to take a piece of tissue from the terminal ileum (lowest part of the small bowel adjacent to the caecum) which, when examined microscopically, shows small bowel mucosa. The gastroenterologist did not do this. The gastroenterologist was over-confident in his assessment of his ability to pass the colonoscope to the caecum and in his assumption that he had done so in Mrs V's case. Had the gastroenterologist's report indicated that the colonoscopy did not rule out the diagnosis of carcinoma of the caecum the consultant surgeon's actions and decisions on the 1st September may have been different.

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10.4 Accurate diagnosis depends on clinical evaluation by history and physical examination, supported by appropriate investigations. It is the clinician's responsibility to be familiar with the accuracy and limitations of the investigations that he uses. The consultant surgeon's initial clinical impression was that Mrs V had a carcinoma of the caecum and he arranged for her to have appropriate investigations to confirm this diagnosis. When he saw her in the out-patient department on 1 September 1997 with the results of the investigations, which failed to support his clinical diagnosis, he should not have unquestioningly accepted the investigation results. He should have been aware of the limitations of the investigations and, on the knowledge of the level of Mrs V's anaemia at presentation in April and his clinical impression of the possibility of a mass in the right lower abdomen at that time, he should have re-examined her. The assessors are of the view that had he done so the diagnosis would have been made on that day. The delay in the diagnosis of Mrs V's cancer was due to a combination of a suboptimal barium enema, an over-confident colonoscopy report and the unquestioning acceptance of these negative results, which were unexpected, without further clinical evaluation by physical examination.

10.5 Carcinoma of the caecum can present major difficulties in diagnosis due to its occult (hidden) nature, and the standard investigations are often reported as normal. The assessors are of the view that the failings of the consultant radiologist, the gastroenterologist and the consultant surgeon outlined above led to Mrs V's care being less than ideal.

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Annex B

GLOSSARY OF TERMS

Gastroscopy

an inspection of the interior of the stomach

Hiatus hernia

a protrusion of part of the stomach through the hiatus of the diaphragm (muscle between chest and abdominal cavities)

Barium enema

a suspension of barium injected into colon as a contrast agent for radiological examination

Diverticular disease

diverticula are small pouches of the lining of the large bowel associated with thickening of the bowel muscle

Diverticulitis

when the diverticula are inflamed

Colonoscopy

flexible fibreoptic examination which permits visualisation of the entire colon by passing a colonoscope through the rectum (back passage)

Caecum

the first part of the colon

Palpated

felt carefully with hands and fingertips

Screen control

continued visualisation 'on screen'

Proximal transverse colon

portion of the colon that runs transversely across the upper part of the abdomen

Faecal residue

waste matter normally present in the bowel but usually cleared by preparation prior to bowel investigation

Iliac fossa

lower abdomen to one side

Terminal ileum

lowest part of the small bowel adjacent to the caecum

Occult

not visible to the naked eye

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Last updated: 9 January 2006

     
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