Bruce D. George

A randomized, controlled trial of fibrin glue vs. conventional treatment for anal fistula.

AbstractPURPOSE: Fibrin glue is a novel treatment for anal fistulas and possesses many advantages in the treatment of difficult high fistulas. Fibrin glue treatment is simple and repeatable; failure does not compromise further treatment options; and sphincter function is preserved. We aimed to compare the outcomes of patients with low and high anal fistulas randomly assigned to either fibrin glue or conventional treatment. METHODS: Patients with simple fistulas (low fistulas) and complex fistulas (high, Crohn’s, and low fistulas with compromised sphincters) were randomly assigned to either fibrin glue or conventional treatment (fistulotomy or loose seton insertion with or without subsequent advancement flap). Patients with rectovaginal fistulas and anal fistulas associated with chronic cavities, acute sepsis, and side branches were excluded. The primary end point was fistula healing. Secondary end points were complications, changes in preoperative continence score, changes in maximum resting and squeeze pressure, satisfaction scores, and pain scores and time off work (simple fistulas only). RESULTS: Patients in the fibrin glue and conventional treatment arms were well matched for gender, median age, duration of fistula symptoms, and follow-up. Fibrin glue healed three (50 percent) of six and fistulotomy seven (100 percent) of seven simple fistulas (difference, 50 percent; confidence interval, 10 to 90 percent; P = 0.06, Fisher’s exact probability test). There was no change in baseline incontinence score, maximum resting pressures, or squeeze pressures between the study arms. Return to work was quicker in the glue arm, but pain scores were similar and satisfaction scores higher in the fistulotomy group. Fibrin glue healed 9 (69 percent) of 13 and conventional treatment 2 (13 percent) of 16 complex fistulas (difference, 56 percent; 95 percent confidence interval, 25.9 to 86.1 percent; P = 0.003, Fisher’s exact probability test). There was no change in baseline incontinence score, maximum resting pressures, or squeeze pressures in either study arm. Satisfaction scores were higher in the fibrin glue group. CONCLUSIONS: No advantage was found for fibrin glue over fistulotomy for simple fistulas, but fibrin glue healed more complex fistulas than conventional treatment and with higher patient satisfaction.

Perianal Crohn's disease

The management of perianal Crohns disease is difficult. A wide variety of treatment options exist although few are evidence based.

Quantification of histologic regression of rectal cancer after irradiation: A proposal for a modified staging system

AbstractPURPOSE: Long-course preoperative radiotherapy has been recommended for rectal carcinoma when there is concern about the ability to perform a curative resection, for example, in larger tethered tumors or those sited anteriorly or near the anal sphincter. “Downstaging” of the tumor may occur, and this is of importance when estimating the prognosis and selecting postoperative therapy for patients. We studied the effects of preoperative chemoradiotherapy on the pathology of rectal cancer, and we propose a simplified measurement of tumor regression, the Rectal Cancer Regression Grade. METHODS: We have reviewed those patients who received preoperative chemoradiotherapy followed by surgical resection for carcinomas of the mid or distal third of the rectum found to be Stage T3/4 on transrectal ultrasound or CT between January 1995 and December 1998. Patients received 45 to 50 Gy irradiation and an infusion of 5-fluorouracil. The surgical specimens were examined by one pathologist, and the Rectal Cancer Regression Grade was quantified. RESULTS: Forty-two patients, mean age 60 (range, 42–86) years, underwent chemoradiotherapy before surgery for rectal carcinoma. There were 28 anterior resections (67 percent; 9 with a colonic pouch), 12 abdominoperineal resections (27 percent), and 2 Hartmann’s procedures (5 percent). Comparison of preoperative and pathologic staging revealed that the depth of invasion was downstaged in 17 patients (38 percent), and the status of involved lymph nodes was downstaged in 13 (50 percent) of 26 patients. Tumor regression was more than 50 percent (Rectal Cancer Regression Grades 1 and 2) in 36 patients (86 percent), with 7 patients (17 percent) having complete regression with absence of residual cancer cells. CONCLUSION: Significant tumor regression was seen in 86 percent of cases after chemoradiotherapy, with 19 patients showing a “good” responsiveness. We propose a modified pathologic staging system for irradiated rectal cancer, the Rectal Cancer Regression Grade, which includes a measurement of tumor regression. The utility of the proposed Rectal Cancer Regression Grade must be tested against long-term outcomes before its value in predicting prognosis and survival can be determined.

The Treatment of Anal Fistula: ACPGBI Position Statement

Anal fistula is common. It usually causes pain and discharge of pus from the external opening which may be continuous or intermittent. These symptoms should not be underestimated. They often cause great discomfort and can make the patient’s life a misery. Assessment requires an understanding of the pathological anatomy. This is achieved by digital examination and, in complex cases, by imaging using ultrasound or magnetic resonance imaging (MRI) or both. The key to successful treatment is to eradicate the primary track. In most patients this is carried out by laying open the fistula (fistulotomy), an operation which has been performed since mediaeval times as described by John of Arderne in the 14th century. Where it is deemed that fistulotomy may lead to a disturbance of continence, other procedures are available. These include the use of a seton, advancement flap procedures or attempts to occlude the fistula track by biological substances. Anal sepsis can arise in association with Crohn’s disease, human immunodeficiency virus (HIV) infection, ileoanal pouch anastomosis, malignancy and tuberculosis.

Preoperative chemoradiotherapy and total mesorectal excision surgery for locally advanced rectal cancer: Correlation with rectal cancer regression Grade

PURPOSEPreoperative long-course chemoradiotherapy is recommended for rectal carcinoma when there is concern that surgery alone may not be curative. Downstaging of the tumor can be measured as rectal cancer regression grade (1-3) and may be of importance when estimating the prognosis. The aim of this study was to look at the long-term results of tumor regression in patients receiving long-course chemotherapy before surgical resection of rectal cancer.METHODSWe reviewed those patients who received preoperative chemoradiotherapy followed by surgical resection for carcinoma of the mid rectum or distal rectum found to be stage T3/4 between January 1995 and November 1999. Patients received 45 to 50 Gy irradiation in 2-Gy fractions and an infusion of 5-fluorouracil. Surgical specimens were assessed for rectal cancer regression grade. Patients were followed up routinely with clinical examination, computed tomography, and colonoscopy.RESULTSSixty-five patients with a mean age 65 (range, 32–83) years underwent chemoradiotherapy before surgical resection. Thirty patients (46 percent) were classified as rectal cancer regression Grade 1, with 9 patients (14 percent) having complete sterilization of the tumor. Fifty-three patients (82 percent) underwent a curative resection. Overall survival, with a median follow-up of 39 (range, 24–83) months, was 67 percent and was associated with tumor downstaging. The local recurrence rate was 5.8 percent in those patients who underwent a curative resection and was significantly lower with rectal cancer regression Grade 1 tumors (P = 0.03). Eight of nine patients (89 percent) whose tumor had been sterilized were alive and well with no recurrence of tumor at a median follow-up of 41 (range, 24–70) months.CONCLUSIONSPreoperative chemoradiotherapy resulted in significant regression of tumor. Overall survival was high and was associated with downstaging of tumor. The local recurrence rate was significantly lower with rectal cancer regression Grade 1 tumors and was not seen in patients with sterilized tumors.

The management and outcome of anastomotic leaks in colorectal surgery

Purpose  Anastomotic leaks in colorectal surgery are associated with significant morbidity and mortality and may result in poor functional and oncological outcomes. Diagnostic difficulties may delay identification and appropriate management of leaks. The aim of this study was to look at the diagnosis, clinical management and outcomes of anastamotic leaks in our department.

Delayed surgery for acute severe colitis is associated with increased risk of postoperative complications

This study determined the long‐term outcome after colectomy for acute severe ulcerative colitis (ASUC) and assessed whether the duration of in‐hospital medical therapy is related to postoperative outcome.

Local excision of rectal tumours by transanal endoscopic microsurgery

Transanal endoscopic microsurgery (TEM) allows locally complete excision of rectal tumours and provides an alternative to conventional surgery for benign tumours. However, its role in the curative treatment of invasive carcinoma is controversial. The aim of this study was to determine the morbidity and long‐term results for rectal tumours excised by TEM.

Randomized, Double-Blind, Placebo-Controlled Trial of Sildenafil (Viagra®) for Erectile Dysfunction After Rectal Excision for Cancer and Inflammatory Bowel Disease

AbstractPURPOSE: Controlled trials have demonstrated the efficacy of sildenafil for “mixed etiology” erectile dysfunction, but this may not be the case if there is underlying pelvic parasympathetic nerve damage. We aimed to determine the efficacy of sildenafil after rectal excision for rectal cancer and inflammatory bowel disease. METHODS: Patients with erectile dysfunction after rectal excision were randomly assigned in a double-blind manner to sildenafil or placebo groups. After unblinding, placebo patients crossed over to open sildenafil. Primary end points were improvement in erectile function on a global efficacy question and erectile function questionnaire scores. Secondary end points were frequency and severity of side effects. RESULTS: Thirty-two patients were randomly assigned, and two dropped out before randomization. Fourteen received sildenafil, and 18 received placebo. Eleven (79 percent) of 14 responded to sildenafil, on global efficacy assessment, compared with 3 (17 percent) of 18 taking placebo (mean difference, 61.9 percent; 95 percent confidence interval, 34.4 to 89.4 percent; P = 0.0009). Sildenafil improved both erectile function domain scores (mean difference, 13.3; 95 percent confidence interval, 7.9 to 18.7; P = 0.0001) and total International Index of Erectile Function scores (mean difference, 30.6; 95 percent confidence interval, 18.7 to 42.6; P < 0.0001) from pretreatment baseline scores. Placebo did not produce improvement in either erectile function (mean difference, 1.7; 95 percent confidence interval, −0.8 to 4.2; P = 0.16) or total International Index of Erectile Function scores (mean difference, 5; 95 percent confidence interval, −1.1 to 11.1; P = 0.1). Ten (100 percent) of 10 crossover patients not responding to placebo did respond to sildenafil (difference, 100 percent; P < 0.0001). Sildenafil improved both erectile function domain scores (mean difference, 16.8; 95 percent confidence interval, 9.7 to 24; P = 0.002) and total International Index of Erectile Function scores (mean difference, 29.5; 95 percent confidence interval, 15.8 to 43.2; P = 0.003) from precrossover baseline scores. Seven (50 percent) of 14 patients on sildenafil compared with 4 (22 percent) of 18 on placebo experienced side effects (difference, 28 percent; 95 percent confidence interval, −4.4 to 60.4 percent; P = 0.14), 91 percent of which were mild and well tolerated. CONCLUSION: Sildenafil completely reverses or satisfactorily improves postproctectomy erectile dysfunction in 79 percent of patients. Side effects are usually mild and well tolerated. The damage incurred by the pelvic nerves after proctectomy, less profound than after prostatectomy, is likely to result in a partial parasympathetic nerve lesion.

Recurrence after abdominal surgery for Crohn's disease. Relationship to disease site and surgical procedure

AbstractPURPOSE: We investigated the hypothesis that there is an “aggressive” subtype of Crohn’s disease characterized by early recurrence and that disease location and surgical procedure are associated with differing patterns of recurrence. METHODS: We analyzed 280 patient records totaling 482 major abdominal operations from a prospectively compiled Crohn’s disease database. Patterns of recurrence, as defined by reoperation, were analyzed by Kaplan-Meier plots and log-rank tests for the group as a whole, as well as according to disease location and operation performed using log-rank and Cox regression analysis. RESULTS: The overall survival curve followed a simple curve with no apparent early rise in recurrence. There was a significantly higher recurrence rate for ileal disease than for ileocolic or colic disease (median reoperation-free survival, 37.8 vs. 47.8 and 54.7 months, respectively; log-rank test = 13.6; P = 0.001), and there was a significantly shorter reoperation-free survival for those patients treated by strictureplasty alone or strictureplasty combined with resection than for those treated by resection alone (41.7 and 48.6 vs. 51 months, respectively; log-rank test = 12; P = 0.002), but only disease site was confirmed as an independent risk factor for recurrence by multiple regression analysis. CONCLUSIONS: These data suggest that there is no evidence for the existence of a separate, early recurring, aggressive disease type. Shorter reoperation-free survival after strictureplasty may reflect patterns of recurrence in ileal disease.