Results of collagen plug occlusion of anal fistula: a multicentre study of 126 patients.

AIM: The Biodesign(®) anal fistula plug was introduced as a means of obliterating the fistula tract and promoting healing through biocompatibility. The results demonstrated unexplained variations from good to bad. This report analysed the results of a retrospective multicentre study. METHOD: All plug procedures performed in four Stockholm hospitals between June 2006 and June 2010 were identified and studied using a common protocol. The outcome after the first plug-insertion procedure was assessed by chart review performed a minimum of 8 months after plug insertion. Cox proportional-hazards models were used to assess the associations of various factors with fistula healing. RESULTS: One-hundred and twenty-six patients (mean age 47 years) were deemed suitable for the plug procedure. Eighty-five per cent of fistulae were cryptoglandular, 64% of patients were male and a mean of 2.9 previous fistulae procedures had been performed. All patients, except four, had an indwelling seton at the time of the plug procedure, which was performed in accordance with previously established principles of day surgery. After a median of 13 months, 30 (24%) fistulae had closed with no discomfort or secretion reported. The outcome in the four hospitals varied from 13% to 33% with similar numbers of patients in each hospital. A success rate of 12% was observed for patients with anterior fistula compared with 32% for those with posterior tracks [hazard ratio (HR) for successful healing = 2.98; 95% CI: 1.01-8.78) and 41% for those with a lateral internal opening (HR = 3.76; 95% CI: 1.03-13.75). Age, sex and number of previous procedures were not associated with healing. CONCLUSION: Four independent patient groups showed low success rates after the first plug-insertion procedure. Anterior fistulae were much less likely to heal compared with fistulae in other locations.

Outcome of 132 consecutive reconstructive operations for intestinal fistula--staged operation without primary anastomosis improved outcome in retrospective analysis.

AIM: To study factors that influenced healing and survival after attempted closure of enterocutaneous fistula. MATERIAL AND METHODS: Retrospective analysis of prospective data concerning 101 patients operated on 132 instances for 110 enterocutaneous fistulae at two hospitals. RESULTS: In all, 96 (87%) of the 110 fistulae healed and 92 (91%) patients survived. A total of 9 patients with unhealed fistula died. Multivariate analysis revealed jaundice as an independent factor for both death and failed closure and operation without anastomosis as an independent positive factor for healing. Failure rate was lower after an operation with stoma without anastomosis (6 of 43, 14%) than after an operation with anastomosis (30 of 89, 34%) p = 0.0213. Of the 36 instances with unhealed fistula, 13 (36%) could be ascribed to inadvertent bowel lesions at the reconstructive operation. In addition, univariate analysis revealed that patients with previous multiple laparotomies or with multiple operations for enterocutaneous fistula healed less likely and had higher mortality. A low serum albumin, high white blood cell count, high C-reactive protein concentration, high fistula output, total parenteral nutrition, and operation for recurrent fistula were associated with death together with long operation time and operative bleeding, both indicators of surgical complexity. Over time, staged surgery avoiding anastomosis increased from 27% to 57%. Mortality decreased from 12% to 6%, and healing increased from 73% to 94%. CONCLUSIONS: Chronic inflammation, malnutrition, and liver failure causing an impaired healing capacity are important reasons for failure. Staged operation without primary anastomosis may allow the patient to reverse this condition and improve outcome. The high surgical complexity is a negative factor that requires careful planning of the operation.

Long-term results of stapled haemorrhoidopexy in a prospective single centre study of 153 patients with 1-6 years' follow-up.

AIM: The long-term results of stapled haemorrhoidopexy for prolapsed haemorrhoids were assessed using uniform methods to acquire data and pre-set definitions of failure, recurrence, residual symptoms and impaired continence. METHOD: From October 1999 to May 2005, 153 patients underwent a stapled haemorrhoidopexy and were enrolled prospectively. They were assessed preoperatively, postoperatively and at the end of the study from replies to a questionnaire about symptoms and continence. Preoperatively, manual reduction of prolapse was required in 103 patients, skin tags were found in 115 patients (circumferential in 22) and impaired continence in 63. RESULTS: In all, 145 patients completed preoperative and long-term protocols and were analysed as paired data, at a mean follow-up of 32 months. Failure to control the prolapse or recurrence was seen in 19 (13%) patients including nine reoperations for prolapse. Symptoms improved from 8.1 to 2.5 points on a 15-point scale (P = 0.001). Symptoms were not controlled in 25 (17%) patients. Continence improved from 4.7 to 2.9 points on a 15-point scale (P = 0.001). Twenty-five (17%) patients still had a continence disturbance. Altogether 51 (35%) patients had a deficient outcome with respect to prolapse, symptoms or continence. There were no major adverse events. CONCLUSION: Restoration of the anal anatomy by stapled haemorrhoidopexy resulted in a significant improvement in haemorrhoid-associated symptoms and continence but a third of patients had poor symptom control including 13% with persisting prolapse.

Endoanal ultrasonography may distinguish Crohn's anal fistulae from cryptoglandular fistulae in patients with Crohn's disease: a cross-sectional study.

BACKGROUND: The aim of the study was a cross-sectional investigation into the types of anal fistulae in patients with Crohn's disease using 3-dimensional endoanal ultrasonography. METHODS: The study population consisted of 45 patients with established Crohn's disease referred in a 2-year period for treatment of anal fistula. The fistulae were classified according to the presence of three criteria: 1. bifurcation or secondary extension; 2. cross-sectional width ≥ 3 mm; and 3. content of hyperechoic secretions. RESULTS: The fistulae of 24 patients (53%) satisfied two or three criteria and were classified as true Crohn's fistulae, while the fistulae of 21 patients satisfied one or none of the criteria and were the cryptoglandular type. The fistulae in the two or three criteria group had been in existence for 8.4 years on average and those in the cryptoglandular group for 4.5 years on average (P = 0.283). The corresponding numbers of previous operations for fistula were 5.7 (range 0-32) and 1.5 (range 0-6), respectively (P = 0.0211). The presence of colitis or proctitis was similar across the groups, but the perianal Crohn's disease activity index was higher with a Crohn's type of fistula (P = 0.0097). Also, a larger proportion had been treated with anti-TNF-monoclonal antibody (0.0169). CONCLUSIONS: Endoanal ultrasonography was capable of discerning two subgroups of fistula in Crohn's patients. These groups were clinically different indicating that the prospect of surgical cure is also different.

Analysis of outcome of Lichtenstein groin hernia repair by surgeons-in-training versus a specialized surgeon.

PURPOSE: Groin hernia repair is a common procedure in general surgery, and is taught to and performed by surgeons early in their training. The aim of this observational study was to compare hernia repair performance and results of surgical trainees with those of a specialized surgeon, to identify what factors may influence short and long-term outcome, and areas for improvement in surgical training. METHODS: A non-randomized parallel cohort study was designed; 200 Lichtenstein repairs in adult males were included, of which 96 were performed by surgical trainees. Patient characteristics, surgical experience, and operative data, including duration of procedural parts and surgical complexity, were noted at surgery. Postoperative complications, recurrence, chronic pain and residual symptoms were assessed at long-term follow-up after a median of 34.5 months. RESULTS: Surgical trainees required longer overall operative time, with a disproportionally longer time for mobilizing the sac and cord. They perceived exposure and mobilization as more difficult than the specialist, and also a greater demand on their own experience during surgery. The trainee repairs had a higher rate of postoperative complications (14.7% vs 5.0%) but recurrence rate was the same as for specialist repairs. At long-term follow-up, specialist repairs had higher symptom burden and more chronic pain. CONCLUSIONS: It was more efficient, but not necessarily better, to let a specialized surgeon perform the repairs. It seems likely that targeted training in dissection and mobilization could decrease level of perceived complexity and shorten the operative time required by surgical trainees.

Randomized clinical trial of symptom control after stapled anopexy or diathermy excision for haemorrhoid prolapse.

BACKGROUND: : This multicentre randomized clinical trial studied how symptoms improved after either stapled anopexy or diathermy excision of haemorrhoids. METHODS: : The study involved 18 hospitals in Sweden, Denmark and the UK. Some 207 patients were randomized to either anopexy or Milligan-Morgan haemorrhoidectomy, of whom 90 in each group were operated on. Patients reported symptoms before surgery and after 1 year. Daily postoperative pain scores were recorded in a patient diary. Surgeons evaluated the anal anatomy before surgery and after 1 year. RESULTS: : Correction of prolapse in the anopexy and haemorrhoidectomy groups was similar at 1 year (88 and 90 per cent respectively; P = 0.80). Freedom from symptoms was obtained in 44 and 69 per cent respectively (P = 0.002). Stapled anopexy was associated with less postoperative pain, which resolved more quickly (P = 0.004). Significant improvements were noted in anal continence and well-being 1 year after both operations (P < 0.001). Excessive pain was the most common complication after diathermy excision and disturbed bowel function after stapled anopexy. CONCLUSION: : Haemorrhoidal prolapse was corrected equally by either operation. Diathermy haemorrhoidectomy gave better symptom relief but was more painful. Neither operation provided complete cure but well-being was greatly improved. REGISTRATION NUMBER: ISRCTN68315343 (http://www.controlled-trials.com).

Randomized clinical trial of stapled haemorrhoidopexy performed under local perianal block versus general anaesthesia.

BACKGROUND: The aim was to assess the feasibility of performing stapled haemorrhoidopexy under local anaesthesia. METHODS: Fifty-eight patients with haemorrhoid prolapse were randomized to receive local or general anaesthesia. The perianal block was applied immediately peripheral to the external sphincter. Submucosal block was added after applying the purse-string suture. Patients reported average and peak pain daily for 14 days using a visual analogue scale (VAS). They also completed anal symptom questionnaires before the operation and at follow-up. The surgeon assessed the restoration of the anal anatomy 3-6 months after surgery. RESULTS: The anal block was sufficient in all patients. The mean accumulated VAS score for average pain was 23.1 in the general anaesthesia group and 29.4 in the local anaesthesia group (P = 0.376); mean peak pain scores were 42.1 and 47.9 respectively (P = 0.537). Mean change in symptom load was also similar between the groups, with score differences of 7.0 in the general anaesthesia group and 6.1 in the local anaesthesia group. No patient had a recurrence of prolapse. CONCLUSION: Perianal local block is easy to apply with a high degree of acceptability among patients. Postoperative pain, restoration of anatomy and symptom resolution were similar to that of stapled haemorrhoidopexy performed under general anaesthesia. REGISTRATION NUMBER: ISRCTN19930199 (http://www.controlled-trials.com).

Grade of prolapse and symptoms of haemorrhoids are poorly correlated: result of a classification algorithm in 270 patients.

PURPOSE: Haemorrhoid prolapse is an indication for surgery. A correlation between worsening anatomy and increasing symptoms is commonly assumed. We developed a classification algorithm of prolapse and external component, and evaluated its correlation to symptoms before and after surgery. METHOD: A study population comprising 180 patients operated for haemorrhoids in a multicentre randomized trial plus a validation set comprising 90 patients operated by us. The classification used three items: (i) patient self-report of prolapse requiring manual reposition; (ii) surgeon assessment of prolapse when patient negated manual reposition; (iii) surgeon assessment of external component. Patient self-reported were rated by frequency (never, 0 points; monthly, 1 point; weekly, 2 points and daily, 3 points). The algorithm yielded three grades: 1, no prolapse; 2, spontaneously reducing prolapse and 3, prolapse needing manual repositioning. The degree of external component was affixed as A, none; B, one or few tags and C, circumferential. RESULTS: Anatomical grades did not differ between the two sets of patients before or after surgery. Preoperatively, 69% had grade 3 prolapse. Postoperatively, 89% were classified as grades 1A or B. The symptom load was similar for grades 2 and 3; mean 6.5 points preoperatively and 1.8 points postoperatively. CONCLUSION: This anatomical classification, based on strict criteria, reliably staged the haemorrhoid prolapse. There was no unique preoperative symptom profile associated with any degree of prolapse with or without an external component. Restored anal anatomy relieved symptoms. The classification also defined recurrence of haemorrhoids.

Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection.

BACKGROUND: Recent studies have suggested that MBP does not lower the risk of postoperative septic complications after elective colorectal surgery. This randomized clinical trial assessed whether preoperative MBP is beneficial in elective colonic surgery. METHODS: A total of 1505 patients, aged 18-85 years with American Society of Anesthesiologists grades I-III, were randomized to MBP or no MBP before open elective surgery for cancer, adenoma or diverticular disease of the colon. Primary endpoints were cardiovascular, general infectious and surgical-site complications within 30 days, and secondary endpoints were death and reoperations within 30 days. RESULTS: A total of 1343 patients were evaluated, 686 randomized to MBP and 657 to no MBP. There were no significant differences in overall complications between the two groups: cardiovascular complications occurred in 5.1 and 4.6 per cent respectively, general infectious complications in 7.9 and 6.8 per cent, and surgical-site complications in 15.1 and 16.1 per cent. At least one complication was recorded in 24.5 per cent of patients who had MBP and 23.7 per cent who did not. CONCLUSION: MBP does not lower the complication rate and can be omitted before elective colonic resection. REGISTRATION NUMBER: ISRCTN28535118 (http://www.controlled-trials.com).

Excision of residual skin tags during stapled anopexy does not increase postoperative pain.

OBJECTIVE: We studied whether excision of residual external skin tags causes additional pain in patients undergoing a stapled anopexy for muco-anal prolapse. METHOD: Seventeen patients in whom skin tags had been excised were compared with 24 patients having no excision. The patients were selected from a prospective database of haemorrhoid surgery if they had submitted a diary with self-reported postoperative pain scores as well as a self-reported symptom questionnaire preoperatively and postoperatively. The tags were excised with preservation of the subdermal fascia. RESULTS: There were 41 patients who fulfilled the criteria for inclusion. Seventeen (group 1) had tags excised and 24 (group 2) did not. Fifty-nine per cent in group 1 and 67% in group 2 experienced preoperative prolapse needing manual reposition. The mean height of the staple line was 2 cm above the dentate line in both groups. Daily average postoperative pain recorded as the sum of a self-reported VAS rating over 14 days was 26 points in both groups. The peak pain experienced was 42 and 43 points respectively (not significant). Resolution of postoperative pain over 14 days was identical. The preoperative and postoperative symptom score was comparable in both groups. CONCLUSION: Excision of anal skin tags should be carried out at the time of stapled anopexy.

An evidence-based treatment algorithm for anal fissure.

Guidelines for the treatment of anal fissure have been published in the USA and UK but differ. Many centers follow guidelines based on local experience. In December 2005, we met with the aim of developing an evidence-based treatment algorithm for anal fissure, applicable to both primary and secondary care. This algorithm may rationalize the treatment of anal fissure in primary and secondary care settings.

Consensus conference on the stapled transanal rectal resection (STARR) for disordered defaecation.

An international working party was convened in Rome, Italy on 16-17 June, 2005, with the purpose of developing a consensus on the application of the circular stapling instrument to the treatment of certain rectal conditions, the so-called Stapled Transanal Rectal Resection (STARR). Since the procedure has been submitted to only limited objective analysis it was felt prudent to hold a meeting of interested individuals for the purpose of evaluating the current status and to make conclusions and recommendations concerning the applicability of this new approach.

[Enterocutaneous fistulas--persisting conditions but the healing capacity can be surgically restored. Current treatment and surgical skills reduce the mortality]. / Enterokutana fistlar--krävande tillstånd som kan opereras till läkning. Modern behandling och kirurgisk erfarenhet minskar mortaliteten.

Persisting enterocutaneous fistulae are difficult to treat. Mortality and morbidity are high. Patients are characterized by chronic infection, systemic inflammation, catabolism and impaired healing. During 1988-2002 69 patients were operated at the University Hospital, Linköping. The mortality was 18% in 1988 to 1996 but decreased to 7% in 1997 to 2002 after establishment of present treatment strategies. It's main feature is staged surgery rising ostomies rather than doing primary anastomoses. The ostomies are closed several months later when infection and systemic inflammation are overcome and nutrition and healing capacity are restored. All patients that survived healed their fistula after surgery. Open abdomen, high output fistulas, impaired liver function and a low serum albumin were associated with a poor prognosis for healing and mortality. Effective techniques for management of abdominal defects, methods to establish enteral nutrition, minimize chronic inflammation and liver impairment as well as operative techniques and strategies are important.

Local perianal block for anal surgery.

BACKGROUND: We refined a technique for local block of all terminal nerve branches to the anus. METHODS: A total of 30 consecutive patients with proctological disorders consented to ambulatory (n=29) or hospitalised (n=1) operation with local perianal block for skin tags, Milligan- Morgan haemorrhoidectomy, stapled haemorrhoidopexy or anocutaneous fistulae. Patients were operated prone. A total of 40 ml of a 4.75 mg/ml solution of ropivacaine (Narop; Astra, Sweden) was injected in 8 directions (5 ml each) into the ischiorectal fat immediately peripheral to the external sphincter as anaesthetic columns reaching from the skin to the levator. This injection scheme targets the terminal nerve branches of the anus rather than blocking the trunk of major nerves. The relaxation of a pain-free anus was obtained in 2-3 minutes with exposure similar to a general anaesthetic. Postoperative pain was evaluated on a 0 to 10 visual analogue scale (VAS). RESULTS: Patients were pain-free at discharge. However, mean postoperative VAS score at 24 hours was 3.2 following Milligan-Morgan haemorrhoidectomy, 4.8 following stapled haemorrhoidopexy and skin tags or polyps excision, and 2.7 after fistula lay-open. At telephone follow-up 1-2 weeks later, the patients were satisfied with the method of anaesthesia and would willingly accept it for any further anal surgery. CONCLUSIONS: The perianal block is easy to apply and effective as sole method of anaesthesia for proctological operations.

Stapled haemorrhoidopexy: a consensus position paper by an international working party - indications, contra-indications and technique.

An international working party with experience in the performance of an alternative haemorrhoid operation through the use of the circular stapler was convened for the purpose of developing a consensus as to the criteria for undertaking this procedure. The agenda consisted of first, naming the operation; second, the indications and contra-indications for its performance; and third, the preferred surgical technique. Among the recommendations for individuals who plan to embark on this surgery are that experience with anorectal surgery and an understanding of anorectal anatomy are requisites; experience with circular stapling devices is essential; and the surgeon must attend a formal course which should include lectures, videos, the application of the instrument in models, and observation of the operation as performed by a surgeon recognized by his or her peers-leading ultimately to undertaking the procedure while being observed by an experienced surgeon. Following satisfactory completion of the above, independent responsibility should be determined by an individual's department of surgery.

Surgery for Crohn colitis over a twenty-eight-year period: fewer stomas and the replacement of total colectomy by segmental resection.

BACKGROUND: This study describes how surgery for Crohn colitis developed between 1970 and 1997, towards the end of which period limited resection and medical maintenance treatment was introduced. METHODS: A cohort of 211 patients with Crohn colitis (115 population-based), of which 84 had a primary colonic resection (42 population-based), was investigated regarding indication for surgery, the time from diagnosis to operation, type of primary colonic resection, risk for permanent stoma and medication over four 7-year periods. RESULTS: Comparison of the periods 1970-90 and 1991-97 revealed that active disease as an indication for surgery decreased from 64% to 25% (P<0.01) while stricture as an indication increased from 9% to 50% (P < 0.001). Median time from diagnosis to operation increased from 3.5 to 11.5 years (P < 0.01). Proctocolectomy or colectomy fell from 68.8% to 10% of the primary resections, whereas segmental resection increased from 31.2% to 90%. At the end of the first 7-year period, 26% had medical maintenance treatment, steroids or azathioprine taken by 7%. Corresponding figures for the last period were 70% and 49%. Patients diagnosed during the last two time-periods had less risk for surgery (P = 0.017), permanent stoma (P < 0.01) and total colectomy (P < 0.01). Findings were similar in the population-based cohort. CONCLUSIONS: Current management of Crohn colitis implies a longer period between diagnosis and surgery, a reduced risk for surgery and permanent stoma, and the replacement of total colectomy by segmental resection.

Safety of the temporary loop ileostomy.

OBJECTIVE: To evaluate the complications of the temporary loop ileostomy. METHOD: A retrospective study of 222 consecutive patients with low anterior resection, ileal pouch-anal anastomosis or continent ileostomy and a diverting loop ileostomy routinely fashioned during the primary operation. The loop ileostomy was closed in 213 patients (96%) during the minimum follow-up period of 15 months. RESULTS: Four patients (2%) required preterm closure of the ostomy due to stomal retraction (n = 3) or bowel obstruction (n = 1). Four patients were readmitted due to transient bowel obstruction that resolved without surgery. After closure of the loop ileostomy a total of 27 patients (13%) had complications. In 7 patients emergency re-operation was done due to small bowel obstruction (n = 5) or intra-abdominal abscess (n = 2). Elective re-operation was done in 5 patients for hernia at the site of the previous stoma. Despite the use of a loop ileostomy there was 1 postoperative death after the initial operation in consequence of anastomotic leakage. There was 1 death in consequence of closure of the loop ileostomy after 3 weeks due to intra-abdominal sepsis and heart failure. CONCLUSION: In this series closure of the ostomy wasassociated with one death (0.5%) and overall ostomy-related morbidity included the need to re-operate in 6%.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol for a controlled clinical trial developed by consensus of an international study group. Part two: design of the study.

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). This part describes the design of the randomised, placebo controlled, double-blinded, single-centre study performed at an university hospital (n = 40 patients for each group). OBJECTIVE: The trial design includes the following elements for a prototype protocol: * The study population is restricted to patients with colorectal cancer, including a left sided resection and an increased perioperative risk (ASA 3 and 4). * Patients are allocated by random to the control or treatment group. * The double blinding strategy of the trial is assessed by psychometric indices. * An endpoint construct with quality of life (EORTC QLQ-C30) and a recovery index (modified Mc Peek index) are used as primary endpoints. Qualitative analysis of clinical relevance of the endpoints is performed by both patients and doctors. * Statistical analysis uses an area under the curve (AUC) model for improvement of quality of life on leaving hospital and two and six months after operation. A confirmatory statistical model with quality of life as the first primary endpoint in the hierarchic test procedure is used. Expectations of patients and surgeons and the negative affect are analysed by social psychological scales. CONCLUSION: This study design differs from other trials on preoperative prophylaxis and postoperative recovery, and has been developed to try a new concept and avoid previous failures.

Granulocyte-colony stimulating factor in the prevention of postoperative infectious complications and sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). Protocol of a controlled clinical trial developed by consensus of an international study group. Part three: individual patient, complication algorithm and quality manage.

GENERAL DESIGN: Presentation of a new type of a study protocol for evaluation of the effectiveness of an immune modifier (rhG-CSF, filgrastim): prevention of postoperative infectious complications and of sub-optimal recovery from operation in patients with colorectal cancer and increased preoperative risk (ASA 3 and 4). A randomised, placebo controlled, double-blinded, single-centre study is performed at an University Hospital (n = 40 patients for each group). This part presents the course of the individual patient and a complication algorithm for the management of anastomotic leakage and quality management. OBJECTIVE: In part three of the protocol, the three major sections include: The course of the individual patient using a comprehensive graphic display, including the perioperative period, hospital stay and post discharge outcome. A center based clinical practice guideline for the management of the most important postoperative complication--anastomotic leakage--including evidence based support for each step of the algorithm. Data management, ethics and organisational structure. CONCLUSIONS: Future studies with immune modifiers will also fail if not better structured (reduction of variance) to achieve uniform patient management in a complex clinical scenario. This new type of a single-centre trial aims to reduce the gap between animal experiments and clinical trials or--if it fails--at least demonstrates new ways for explaining the failures.