Marvin L. Corman

Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection.

IntroductionAlthough Seprafilm® has been demonstrated to reduce adhesion formation, it is not known whether its usage would translate into a reduction in adhesive small-bowel obstruction.MethodsThis was a prospective, randomized, multicenter, multinational, single-blind, controlled study. This report focuses on those patients who underwent intestinal resection (n = 1,701). Before closure of the abdomen, patients were randomized to receive Seprafilm® or no treatment. Seprafilm® was applied to adhesiogenic tissues throughout the abdomen. The incidence and type of bowel obstruction was compared between the two groups. Time to first adhesive small-bowel obstruction was compared during the course of the study by using survival analysis methods. The mean follow-up time for the occurrence of adhesive small-bowel obstruction was 3.5 years.ResultsThere was no difference between the treatment and control group in overall rate of bowel obstruction. The incidence of adhesive small-bowel obstruction requiring reoperation was significantly lower for Seprafilm® patients compared with no-treatment patients: 1.8 vs. 3.4 percent (P < 0.05). This finding represents an absolute reduction in adhesive small-bowel obstruction requiring reoperation of 1.6 percent and a relative reduction of 47 percent. In addition, a stepwise multivariate analysis indicated that the use of Seprafilm® was the only predictive factor for reducing adhesive small-bowel obstruction requiring reoperation. In both groups, 50 percent of first adhesive small-bowel obstruction episodes occurred within 6 months after the initial surgery with nearly 30 percent occurring within the first 30 days. Additionally no first adhesive small-bowel obstruction events were reported in Years 4 and 5 of follow-up.ConclusionsThe overall bowel obstruction rate was unchanged; however, adhesive small-bowel obstruction requiring reoperation was significantly reduced by the use of Seprafilm®, which was the only factor that predicted this outcome.

The safety and efficacy of the artificial bowel sphincter for fecal incontinence: results from a multicenter cohort study.

AbstractPURPOSE: The aim of this trial was to evaluate the safety, efficacy, and impact on quality of life of the Acticon™ artificial bowel sphincter for fecal incontinence. METHODS: A multicenter, prospective, nonrandomized clinical trial was conducted under a common protocol. Patients were evaluated with anal physiology, endoanal ultrasonography, a fecal incontinence scoring system, fecal incontinence quality of life assessment, and overall health evaluation. Patients with a fecal incontinence score of 88 or greater (scale, 1–120) were considered candidates for the study. Implanted patients underwent identical reevaluation at 6 and 12 months postimplant. RESULTS: One hundred twelve of 115 patients (86 females) enrolled were implanted. Mean age was 49 (range, 18–81) years. A total of 384 device-related or potentially device-related adverse events were reported in 99 enrolled patients. Of these events, 246 required no intervention or only noninvasive intervention. Seventy-three revisional operations were required in 51 (46 percent) of the 112 implanted patients. Infection rate necessitating surgical revision was 25 percent. Forty-one patients (37 percent) have had their devices completely explanted, of which 7 have had successful reimplantations. In patients with a functioning neosphincter, improvement in quality of life and anal continence was documented. Mean matched fecal incontinence scores in 63 patients at 6 months follow-up was improved from 105 preimplant to 51 postimplant. In 55 patients at 12 months follow-up, mean matched fecal incontinence scores were 105 preimplant vs. 48 postimplant. A successful outcome was achieved in 85 percent of patients with a functioning device. Intention to treat success rate was 53 percent. CONCLUSIONS: Although morbidity and the need for revisional surgery are high, the artificial bowel sphincter can improve anal incontinence and quality of life in patients with severe fecal incontinence.

A Prospective, Randomized, Controlled Multicenter Trial Comparing Stapled Hemorrhoidopexy and Ferguson Hemorrhoidectomy: Perioperative and One-Year Results

PURPOSEThere is a growing body of evidence supporting the lesser degrees of pain with stapled hemorrhoidopexy, also called the procedure for prolapse and hemorrhoids. However, there have been few randomized comparisons assessing both perioperative and long-term outcomes of the procedure for prolapse and hemorrhoids and Ferguson hemorrhoidectomy. Results are presented here from the first prospective, randomized, multicenter trial comparing these hemorrhoid procedures in the United States.METHODSPatients with prolapsing hemorrhoids (Grade III) were randomized to undergo the procedure for prolapse and hemorrhoids or Ferguson hemorrhoidectomy by colorectal surgeons who had training in using the stapling technique. Primary end points were acute postoperative pain, and hemorrhoid symptom recurrence requiring additional treatment at one-year follow-up from surgery.RESULTSA total of 156 patients (procedure for prolapse and hemorrhoids, 77; Ferguson, 79) completed randomization and the surgical procedure, 18 (procedure for prolapse and hemorrhoids, 12; Ferguson, 6) had significant protocol violations. One hundred seventeen patients (procedure for prolapse and hemorrhoids, 59; Ferguson, 58) returned for one-year follow-up. Demographic parameters, hemorrhoid symptoms, preoperative pain scores, and bowel habits were similar between groups. There were a similar number of patients with adverse events in each group (procedure for prolapse and hemorrhoids, 28 (36.4 percent) vs. Ferguson, 38 (48.1 percent); P = 0.138). Reoperation for an adverse effect was required in six (7.6 percent) Ferguson patients and in 0 patients having the procedure for prolapse and hemorrhoids (P = 0.028). Postoperative pain during the first 14 days, pain at first bowel movement, and need for postoperative analgesics were significantly less in the procedure for prolapse and hemorrhoids group. Control of hemorrhoid symptoms was similar between groups; however, significantly fewer patients having the procedure for prolapse and hemorrhoids required additional anorectal procedures during one-year follow-up (procedure for prolapse and hemorrhoids, 2 (2.6 percent), vs. Ferguson, 11 (13.9 percent); P = 0.01). Only four of the Ferguson patients (5 interventions) required additional procedures more than 30 days after surgery.CONCLUSIONSThese data demonstrate that stapled hemorrhoidopexy offers the benefits of less postoperative pain, less requirement for analgesics, and less pain at first bowel movement, while providing similar control of symptoms and need for additional hemorrhoid treatment at one-year follow-up from surgery.

Anal complications in Crohn's disease.

Anal fissures, fistulas, and abscesses occurred as complications in 22 per cent of our population of 1,098 patients with Crohns disease. Crohns colitis was much more frequently associated with an anal lesion than Crohns disease of the small bowel (52 per cent vs. 14 per cent). When an anal lesion is the manifesting sign, Crohns disease will soon develop elsewhere in the intestine. Since these lesions frequently herald the onset of intestinal Crohns disease, the physician must always be aware of the possibility of inflammatory bowel disease when dealing with suspicions anal lesions.

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.

Long-term results of open and closed sphincterotomy for anal fissure.

Three hundred fifty patients who underwent open or closed lateral internal anal sphincterotomy for acute or chronic anal fissure between January 1981 and June 1985 were reviewed. Minimum follow-up was 14 months (mean, 37 months). No patient underwent an additional procedure at the time of sphincterotomy. Twenty-one failed to heal or developed a recurrence in the interval (6 percent). Five of these individuals were found subsequently to have Crohns disease. Excluding these patients, the incidence of nonhealing was 4.6 percent. Eight patients (2.3 percent) developed postoperative infections requiring drainage, one half of which were associated with fistulas. Sixty patients (17 percent) complained of incontinence for flatus or feces. For two thirds, this was transient. There was no statistically significant difference in rate of healing or morbidity when comparing the open with the closed method.

Safety and effectiveness of temperature-controlled radio-frequency energy delivery to the anal canal (Secca® Procedure) for the treatment of fecal incontinence

PURPOSE This multicenter study evaluated the safety and efficacy of radio-frequency energy delivery to the anal canal for the treatment of fecal incontinence. METHODS Fifty patients at five centers were enrolled. All reported fecal incontinence at least once per week for three months, and medical and/or surgical management failed to help their symptoms. At baseline and at six months, patients completed questionnaires (Cleveland Clinic Florida Fecal Incontinence score (0-20), fecal incontinence-related quality of life, Short Form-36, and visual analog scale) and underwent anorectal manometry, endoanal ultrasound, and pudendal nerve terminal motor latency testing. On an outpatient basis using local anesthesia, radio-frequency energy was delivered via an anoscopic device with multiple needle electrodes (Secca system) to create thermal lesions deep to the mucosa of the anal canal. RESULTS Forty-three females and seven males (aged 61.1 +/- 13.4 (mean +/- standard deviation); range, 30-80 years) were treated. Mean duration of fecal incontinence was 14.9 years. Treatment time was 37 +/- 9 minutes. At six months, the mean Cleveland Clinic Florida Fecal Incontinence score improved from 14.5 to 11.1 (P < 0.0001). All parameters in the Fecal Incontinence Quality of Life scales were improved (lifestyle (from 2.5-3.1; P < 0.0001); coping (from 1.9-2.4; P < 0.0001), depression (from 2.8-3.3; P = 0.0004); embarrassment (from 1.9-2.5; P < 0.0001)). Responders, as assessed by a systematic referenced analog scale, reported a median 70 percent resolution of symptoms. The mean Short Form-36 social function improved from 64.3 to 76 (P = 0.003). There were no changes in endoanal ultrasound or pudendal nerve terminal motor latency assessment, or in anal manometry. Complications included mucosal ulceration (one superficial, one with underlying muscle injury) and delayed bleeding (n = 1). CONCLUSION This multicenter trial demonstrates that radio-frequency energy can be safely delivered to the lower rectum and anal canal. The Secca procedure significantly improved the Cleveland Clinic Florida Fecal Incontinence score and the overall quality of life for most patients having undergone the procedure.

Placement of self-expanding metal stents for acute malignant large-bowel obstruction: A collective review

BackgroundThe purpose of this study was to review our experience with self-expanding metal stents as the initial interventional approach in the management of acute malignant large-bowel obstruction.MethodsTwenty-six patients who underwent placement of colonic stents at our institution between June 1994 and June 2000 were identified and reviewed.ResultsIn 14 patients, the stents were placed for palliation, whereas in 12, they were placed as a bridge to surgery. In 22 patients (85%), stent placement was successful on the first occasion. In the remaining four individuals, one was successfully stented at the second occasion, and three required emergency surgery. Nine of the 12 patients (75%) in the bridge-to-surgery group underwent elective colon resection. In the palliative group, four patients (29%) had reobstruction of the stents, and in one (9%), the stent migrated. In the remaining nine patients (64%), the stent was patent until the patient died or until the time of last follow-up (median, 156 days).ConclusionsIn our experience with 26 patients who developed a complete bowel obstruction as a consequence of a malignant tumor, placement of colonic stents to achieve immediate nonoperative decompression proved to be both safe and effective. Subsequent elective resection was accomplished in the majority of resectable cases.

Comparison of the Valtrac biofragmentable anastomosis ring with conventional suture and stapled anastomosis in colon surgery

In a randomized, prospective study of 438 patients, the safety and efficacy of the Valtrac biofragmentable anastomotic ring (BAR) was compared with stapling and with conventional suture techniques. There was no significant difference in the morbidity, mortality, and clinical course of the patients. The BAR can effect reestablishment of intestinal continuity somewhat more rapidly, but its major advantage is its uniform applicability to all areas of the intestinal tract, except the low rectum.

Prospective, randomized trial of the biofragmentable anastomosis ring

A randomized trial was undertaken to compare the biofragmental anastomotic ring (BAR) with conventional intraperitoneal colorectal anastomotic techniques. Patients were randomized into one of two schemes: BAR versus sutured or BAR versus stapled anastomosis. There were 782 patients entered into the study and 283 patients (36%) had a sutured anastomosis, 104 patients (13%) had a stapled anastomosis, and 395 (51%) had the BAR. Comparison of the BAR with combined suture and stapled controls revealed no significant differences in wound complication, abscess rate, bleeding, anastomotic leaks, ileus, obstruction, or deaths. There were no differences in return of bowel function, return to normal diet, or hospital stay. Intraoperative difficulties occurred in 46 BAR patients (17%), and this was significantly higher (p less than 0.001) than for sutured (3%) but not for stapled anastomoses (11%). The occurrence of these problems did not adversely effect the outcome. The data suggest that the BAR is a safe, satisfactory alternative to sutured or stapled colorectal anastomoses.