Randomized clinical trial of metronidazole ointment versus placebo in perianal Crohn's disease.

BACKGROUND: The potential for metronidazole 10 per cent ointment to exert therapeutic benefit in perianal Crohn's disease, while minimizing the adverse effects found with oral metronidazole, was evaluated in a randomized placebo-controlled study. METHODS: Subjects with perianal Crohn's disease were randomized to metronidazole 10 per cent ointment, 0.7 g applied perianally three times daily, or placebo ointment. The Perianal Crohn's Disease Activity Index (PCDAI) was scored at baseline and after 4 weeks of treatment. Perianal pain was assessed on a visual analogue scale. RESULTS: Seventy-four subjects (33 metronidazole, 41 placebo) were evaluated. The mean(s.e.m.) reduction in PCDAI score at 4 weeks was 2.4(0.5) in the metronidazole group and 2.2(0.4) in the placebo group (P = 0.660). More subjects in the metronidazole group than the placebo group showed a reduction in PCDAI score of at least 5 points (10 of 27 versus 4 of 34; P = 0.031). Perianal discharge was reduced significantly in metronidazole-treated subjects (P = 0.012). A greater reduction in perianal pain was seen in the metronidazole group, which approached statistical significance (P = 0.059). No serious adverse events were reported. CONCLUSION: Metronidazole 10 per cent ointment was not effective in the reduction of PDCAI score, but some secondary outcomes showed improvement suggestive of a treatment effect. It is well tolerated, with minimal adverse effects, and has potential as treatment for pain and discharge associated with perianal Crohn's disease. REGISTRATION NUMBER: NCT00509639 (http://www.clinicaltrials.gov).

The association between referral source and stage of disease in patients with colorectal cancer.

OBJECTIVE: The colorectal fast track (FT) referral system was set up to ensure patients with suspected cases of colorectal cancer (CRC) received prompt access to specialized services. The aim of this study was to ascertain the association between referral source and the time it took to be seen by a colorectal surgeon to establish whether referral source had any association with the stage of disease at presentation in patients with CRC. METHOD: Consecutive patients with newly diagnosed CRC presenting between October 2002 and September 2004 were identified retrospectively. Mode of presentation, symptoms, treatment and histopathology data were analysed. RESULTS: Data for 193 patients were analysed. Ninety seven patients (50%) presented via the FT system, 43 (22.5%) from nonfast track outpatient sources (NFT) and 53 (27.5%) as emergencies. NFT patients took significantly longer to be seen by a colorectal specialist than FT patients (median 69 vs 31 days; P < 0.001) and to initiation of treatment (median 57.5 vs 42.5 days; P = 0.001). Overall 152 patients (79%) presented with symptoms that met the FT criteria. A significantly lower number of NFT (P = 0.001) and emergency patients (P < 0.001) presented with FT symptoms compared with patients referred through the FT system. There was no significant difference between referral groups in patients undergoing surgery with potentially curative intent or stage of disease. CONCLUSION: Nonfast track referral leads to a significant delay in being seen by a specialist and in initiation of treatment but no association with more advanced stage of disease or a reduction in potentially curative surgery was found.

An evaluation of treatment decisions at a colorectal cancer multi-disciplinary team.

OBJECTIVE: It is mandatory for treatment decisions for patients with colorectal cancer to be made within the context of a multi-disciplinary team (MDT) meeting. It is currently uncertain, however, how to best evaluate the quality of MDT decision-making. This study examined MDT decision-making by studying whether MDT treatment decisions were implemented and investigated the reasons why some decisions changed after the meeting. METHOD: Consecutive MDT treatment decisions were prospectively recorded. Implementation of decisions was studied by examining hospital records. Reasons for changes in MDT decisions were identified. RESULTS: In all, 201 consecutive treatment decisions were analysed, concerning 157 patients. Twenty decisions (10.0%, 95% confidence interval 6.3-15.2%) were not implemented. Looking at the reasons for nonimplementation, nine (40%) related to co-morbidity, seven (35%) to patient choice, two changed in light of new clinical information, one doctor changed a decision and for one changed decision, no reason was apparent. When decisions changed, the final treatment was always more conservative than was originally planned and decisions were more likely to change for colon rather than rectal cancer (P = 0.024). CONCLUSION: The vast majority of colorectal MDT decisions were implemented and when decisions changed, it mostly related to patient factors that had not been taken into account. Analysis of the implementation of team decisions is an informative process to monitor the quality of MDT decision-making.

Prevalence of pelvic floor symptoms in female patients attending the two-week wait clinic with suspected colorectal cancer.

Introduction The aim of this study was to establish the prevalence of pelvic floor symptoms in women referred to a colorectal two-week wait (2WW) clinic with suspected colorectal cancer. Methods A questionnaire assessing faecal incontinence (FI) (Wexner score) and obstructed defecation syndrome (ODS) (Renzi score) was offered to 98 consecutive female patients attending a colorectal 2WW clinic at a single trust. Results Overall, 56 (57%) of the 98 patients had significant ODS and/or FI (scores >9/20), 33 (34%) had ODS and 40 (41%) had FI. Seventeen patients (17%) had both ODS and FI. Analysis of the 63 patients referred with a change in bowel habit (CIBH) showed 40 (63%) to be Renzi and/or Wexner positive compared with 16 (46%) of the 35 patients who presented without CIBH (p=0.095, Fisher's exact test). Further analysis showed that 31 (78%) of the 40 patients with FI presented with CIBH compared with 32 (55%) of the 58 without FI (p=0.032). In terms of ODS, 23 (70%) of the 33 patients with ODS presented with CIBH compared with 40 (62%) of the 65 without ODS (p=0.506). Conclusions Over half of the female patients attending our colorectal 2WW clinic had significant pelvic floor dysfunction (FI/ODS), which may account for their symptoms (especially in the CIBH referral category). While it is important for malignancy to be excluded, many patients may benefit from investigation and management of their pelvic floor dysfunction as the cause for their presenting symptoms.

An unusual case of colonic angiodysplasia.

An unusual case of a colonic vascular anomaly resembling angiodysplasia associated with right sided diverticular disease is presented. The patient, a 74 year old man, presented with a four day history of rectal bleeding and subsequently underwent hemicolectomy. The resected specimen was flushed out with heparin-saline solution and injected with a barium-gelatine mixture. Preoperative barium enema revealed right sided diverticula, whereas post-resection angioradiography revealed the "coral reef" vascular anomaly consistent with angiodysplasia. Histology confirmed the presence of both diverticular disease and angiodysplasia. This case report highlights the importance of considering a vascular anomaly in patients presenting with rectal bleeding despite the presence of another radiologically demonstrable anatomical lesion.

Should rubber band ligation of haemorrhoids be performed at the initial outpatient visit?

Despite careful technique, a proportion of patients undergoing rubber band ligation (RBL) of haemorrhoids will experience pain or discomfort. To investigate this, a group of 52 unselected patients presenting to the surgical outpatient clinic of Bristol Royal Infirmary were entered into a prospective study using questionnaires, of which 50 (96%) replied. Pain and discomfort were scored on a 10 cm visual analogue scale. Of these patients, 42 (84%) reported pain in the first 24 h; this was moderate to severe in 9 (18%); 30 (60%) had pain in the second 24 h, with 7 (14%) patients suffering moderate to severe pain. In all, 14 (28%) patients were unable to perform their normal activities on the day of treatment and a further 14 (28%) patients felt faint immediately after RBL. The results of this study indicate that pain after RBL occurs more often than previously recognised. It is suggested that informed consent be obtained before RBL and that patients should be given the opportunity to delay treatment if they so wish.

Definitive repair of anovaginal fistula in Crohn's disease.

Anovaginal fistula may be a very distressing complication of Crohn's disease. We review the definitive repair of such fistulas in ten patients. The objectives were to cure the fistula, maintain continence and avoid proctectomy. The fistula was low trans-sphincteric in five patients, high trans-sphincteric in three and suprasphincteric in two. Loop ileostomies were formed in nine patients. Overall, after 14 repair procedures 8/10 fistulas are healed. Seven remain healed at a mean of 38 months (range 10-66 months) after ileostomy closure (six) or repair without ileostomy (one). All of the patients are continent. Definitive repair is effective and worthwhile in selected patients with Crohn's anovaginal fistula.

Assessment of sutures for use in colonic surgery: an experimental study.

Following injury, normal colon takes approximately 30 days to regain full breaking strength. This healing period can be lengthened by local infection. Colonic anastomoses are likely to be contaminated by intraluminal organisms, and suture material in such a situation is known to potentiate the development of sepsis. Experiments were designed to evaluate six suture materials used in colonic surgery to determine which retained adequate tensile strength and which excited least inflammatory response. The results indicate that absorbable sutures, with the exception of polydioxanone, lose strength too rapidly for use alone. Braided materials, notably silk, produce a prolonged tissue response and harbour bacteria. Monofilament materials are unreactive and appear least likely to delay healing. Polydioxanone, which is monofilament and absorbable, is recommended for use in the colon.

Transanal endoscopic treatment of benign canine rectal tumours: preliminary results in six cases (1992 to 1996).

Transanal endoscopic resection and cautery of benign rectal tumours was performed in six dogs with extensive and/or inaccessible rectal neoplasia. The results were encouraging, with three dogs cured and the quality of life of a further two improved for a significant time. The remaining dog died as a result of rectal perforation. Transanal endoscopic treatment of extensive and/or inaccessible benign canine rectal tumours offers an alternative to more radical techniques such as pull-through surgery.

Single-fiber electromyography correlates more closely with incontinence scores than pudendal nerve terminal motor latency.

BACKGROUND: The investigation of fecal incontinence is important in deciding the most appropriate treatment. The presence of neuropathy has been shown to affect surgical outcomes adversely. Latency studies are of dubious value in assessing neuropathy; needle electromyography is the gold standard test. The relationship between these two tests and the symptoms of fecal incontinence has not been studied. METHOD: A cohort of 57 patients underwent neurologic and symptom assessment using latency studies, concentric and single-fiber electromyography, and symptom assessment using the Cleveland Clinic Scoring System. RESULTS: There was a significant correlation between left mean fiber density and Cleveland Clinic Scoring (correlation: 0.32, P = 0.02) but not between right or left latency studies. CONCLUSION: Single-fiber electromyography gave relevant results that could be obtained easily on modern equipment. Latency values were not reliable.

Fast-track barium enema: meeting the two-week wait rule for patients with suspected colorectal cancer.

OBJECTIVES: To meet the introduction of the two-week wait (TWW) rule for patients with suspected colorectal cancer, a fast-track barium enema (FTBE) service was set up. This study was conducted to evaluate the success of this approach in preparation for meeting the forthcoming targets on waiting times to treatment from referral and diagnosis. METHODS: All patients were offered a double-contrast barium enema within two-weeks, except those with a palpable rectal mass. FTBE were double-reported by specialist gastrointestinal radiologists. Patients with a suspected malignancy were booked for an urgent staging CT and outpatient appointment, whilst the remaining patients were referred back to their general practitioner with a report. Prospective data were collected and two 16-month periods analysed. RESULTS: Three hundred and nine patients had a FTBE over the first 16-month period and 277 (89.6%) were seen within two-weeks. Mean times from initial referral to staging CT and first outpatient appointment were 30.7 and 36.0 days, respectively. Cancer was confirmed histologically in 32 (10.4%) patients. Of 267 patients without a malignancy, 46 (17.2%) were referred back to the colorectal outpatient or endoscopy service within 6-months. The number of referrals increased with time from a mean of 19.3 per month in the first period to 27.8 in the second, but the percentage with a suspected malignancy remained similar at 13.6% and 10.1%, respectively. CONCLUSION: FTBE diagnosed malignancy accurately and facilitated rapid staging. The TWW target was met in almost 90% of patients, whilst the impact on the colorectal outpatient and endoscopy service was minimized.

The effect of malignant and inflammatory fixation of rectal carcinoma on prognosis after rectal excision.

Fixity of colorectal carcinoma at operation seems an important prognostic indicator, perhaps equally as significant as lymph node invasion. A proportion of tumours are, however, tethered by inflammatory adhesions only and, although patients with these tumours should fare better than those with tumours fixed by extramural malignant spread, available data is contradictory. With the recent interest in pre-operative radiotherapy for patients with fixed rectal tumours an in order to clarify the above points we studied 625 patients who had undergone rectal excision a minimum of 10 years previously. Excluding those with disseminated disease, 169 (27 per cent) were fixed, 124 (20 per cent) by direct malignant spread, 45 (7 per cent) by inflammatory tissue. Survival and recurrence rates in these patients were compared with an equivalent number who had mobile lesions. The groups were matched for age, sex and Dukes' stage. The degree of differentiation and height of the lesion above the anal margin were similar. Corrected 5 year survival rates were 28.5 per cent in patients with malignant fixation, 68.9 per cent (P less than 0.01) in those with mobile tumours and 64.6 per cent (P less than 0.01) where the lesion was tethered by inflammation. The incidence of local recurrence in the three groups was 41.3, 15.1 and 20.0 per cent respectively. Five year survival rate in patients with fixed Dukes' B lesions was 43.5 per cent and in patients with mobile C lesions was 62.9 per cent (P less than 0.01). Thus, patients with fixed carcinomas of the rectum have a poor prognosis but only if contiguous spread of the tumour has occurred. These findings have important implications for patients in whom fixity is used as an indication for adjuvant therapy.

Pre-operative evaluation of patients with low rectal carcinoma.

Advances in surgical technique and adjuvant therapy have broadened the spectrum of treatment available for patients with low rectal cancer. Combination of careful pre-operative clinical examination with newer, more sophisticated techniques, particularly in the field of imaging, can stage the extent of disease more accurately then previously. Adoption of an extended pre-operative evaluation allows a more rational approach to treatment in the individual, and standardizes criteria for entry into, and interpretation of, future clinical trials.

Preoperative increase in neuromuscular jitter and outcome following surgery for faecal incontinence.

BACKGROUND: Long-term results of surgery for faecal incontinence remain disappointing. Previous studies have demonstrated that pudendal neuropathy may progress in incontinent patients managed either conservatively or operatively. This progression of pudendal neuropathy may underlie poor long-term results. METHODS: Measurement of neuromuscular jitter by single-fibre electromyography allows the stability of terminal motor axons and end-plates to be assessed before operation. An increase in jitter implies progressive denervation. RESULTS: In this study, patients with increased jitter before operation (n = 14) had significantly worse symptom scores (median (interquartile range (i.q.r)) 14 (9-18) versus 3 (2-8), P = 0.007) and lower squeeze pressures (median (i.q.r.) 23 (21-36) versus 53 (46-60) mmHg, P = 0.015) at 6-month follow-up compared with those with normal jitter before operation (n = 22). CONCLUSION: This study implies that the poor results of surgery are related to progressive denervation and that this may be assessed before operation.

Urge incontinence of faeces is a marker of severe external anal sphincter dysfunction.

A proportion of patients with faecal incontinence experience debilitating urgency of defaecation and urge incontinence. This study prospectively assessed 56 faecally incontinent patients by means of standard interview, physical examination and anorectal physiology. Patients with urge incontinence, when compared with those without urge incontinence, were symptomatically worse, had had more vaginal deliveries and had more bowel actions each day. Physiological tests included anal manometry, anal electrosensitivity, pudendal nerve terminal motor latency and a standard proctometrogram. The only physiological differences between the groups were a reduction in voluntary squeeze pressure (median (interquartile range (i.q.r.)) 43 (26-67) versus 67 (45-122) mmHg, P = 0.01) and a smaller percentage change in pressure-volume, an integral of sphincter length and squeeze (median (i.q.r.) 43.5 (0-289) versus 247 (71-455), P = 0.02), in those with urgency. The authors conclude that urge incontinence is associated with impairment of the striated musculature of the anal sphincter complex.

Serum carcinoembryonic antigen and acute phase reactant proteins in the pre-operative detection of fixation of colorectal tumours.

Fixity of colorectal tumours carries a poor prognosis, but only if it is the consequence of malignant spread. Pre-operative radiotherapy may be beneficial but selection depends on clinical examination which is often inaccurate or impossible. We therefore investigated if serum concentrations of carcinoembryonic antigen and acute phase reactant proteins (APRPS) which may be elevated in patients with colorectal cancer could determine the degree and nature of local spread prior to operation. Carcinoembryonic antigen (CEA), alpha 1 acid glycoprotein (AGP) and C-reactive protein (CRP) were measured pre-operatively in 100 patients with colorectal tumours, 89 of whom had a carcinoma. Thirty-two (36 per cent) were fixed, 18 (56 per cent) by malignancy (FM) and 14 (44 per cent) by inflammation (FI). Levels of CEA, AGP and CRP were all significantly higher in the serum of patients with fixed tumours (P less than 0.05). Concentrations of AGP greater than 1.4 g/l or CRP greater than 15 mg/l were accurate predictors of tumour fixation (specificity 87 and 90 per cent; sensitivity 78 and 78 per cent. CEA appeared more accurate in determining the nature of fixation. A value of greater than 50 ng/ml predicted 82 per cent of FM tumours (specificity 100 per cent; sensitivity 87 per cent). Thus, pre-operative measurement of serum CEA and APRP appear able to predict fixation of colorectal tumours.

Treatment of resistant anal fissure with advancement anoplasty.

OBJECTIVE: The primary aim of this study was to assess the outcome of advancement anoplasty in the treatment of chronic anal fissure, resistant to conventional therapy. The secondary aim was to evaluate the anal resting pressure in these patients with resistant fissures. PATIENTS AND METHODS: Over a five-year period eight patients (2 male, median age 55 years, range 20-74) with resistant anal fissure were referred from 6 centres. They had endured symptoms for a median of 8 years (range 2-20) and had undergone a median of 2 previous surgical procedures (range 1-3), including lateral sphincterotomy and anal dilatation. Anorectal physiological testing was performed on all patients who then underwent advancement anoplasty. The outcome was analysed retrospectively. RESULTS: Pre-operative anorectal physiological testing showed a significantly lowered median maximal anal resting pressure of 42 mm H2O (range 12-72 mm H2O, normal range > 60 mm), P=0.03. All patients underwent advancement anoplasty. At a median of seven months follow-up (range 2-22) seven of eight patients had healed their fissure and were asymptomatic. The median healing time was four months (range 2-6). CONCLUSION: Patients with chronic anal fissure, resistant to conventional therapy, may be successfully treated by advancement anoplasty. Healing time however, may be prolonged. In this series patients had a decreased anal resting pressure rather than anal hypertonia.

Colonoscopy or barium enema as initial investigation of colonic disease.

To determine whether double-contrast barium enema (DCBE) or fibreoptic examination should be the first-line investigation for colonic disease 76 consecutive patients presenting for the first time to the outpatient clinic with symptoms of colonic disease deemed to need a DCBE after negative rigid sigmoidoscopy were entered into a trial. All underwent flexible sigmoidoscopy, then DCBE, and finally colonoscopy. 66 patients completed the study. DCBE alone gave the final diagnosis in 42 (67%) and colonoscopy alone in 60 (91%) (p = 0.0004). A combination of flexible sigmoidoscopy and DCBE led to the diagnosis in 50 patients (76%). With DCBE alone 73% of polyps and 64% of patients with inflammatory bowel disease were missed. No complications arose from the investigations. 32 (48%) patients found DCBE distressing and 15 (23%) found colonoscopy uncomfortable (p = 0.004). Its high diagnostic accuracy and relative lack of discomfort for patients make colonoscopy the primary procedure for investigating patients with large bowel symptoms referred to the general surgeon.

The outcome following sphincter-saving resection and abdominoperineal resection for low rectal cancer.

The introduction of new techniques has enabled more patients with low rectal carcinoma to undergo sphincter-saving resection (SSR). This policy, however, has provoked controversy concerning the adequacy of excision and fear of increased rates of recurrence compared with abdominoperineal resection (APER). We have therefore compared our results of SSR for low and mid-rectal cancers performed between 1978 and mid 1982 with those obtained with APER before this period. One hundred and fifty-nine patients presented with tumours between 3 and 12 cm from the anal verge; 153 (96 per cent) underwent resection, of whom 46 (30 per cent) had disseminated disease. One hundred (68 per cent) underwent SSR, 33 (22 per cent) had an APER and 16 (10 per cent) had a local procedure. Operative mortality was 4 per cent following APER and 7 per cent after SSR (n.s.). Patients were followed for a mean of 4.6 years (range 2-6 years), only four (2.5 per cent) being lost to follow-up. The incidence of recurrence after radical SSR (n = 74) was compared with the historical control group which underwent radical APER, the two groups being matched for Dukes' stage and height of the lesion. After 2 years, local recurrence cumulative rates were 13.6 per cent after SSR and 18.8 per cent after APER. Distant recurrence rates were 14.5 and 20 per cent respectively. Ten patients (13.5 per cent) died of their disease within 2 years of a radical SSR, 15 (15 per cent) after radical APER. Corrected 5-year survival and recurrence rates were similar. Thus, SSR does not appear to carry an increased risk of recurrent disease compared with APER after an equivalent follow-up period.