Frank G. Opelka

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.

Incidence of small-bowel obstruction and adhesiolysis after open colorectal and general surgery

PURPOSE: The study contained herein was undertaken to establish the incidence of small-bowel obstruction, adhesiolysis for obstruction, and additional abdominal surgery after open colorectal and general surgery. METHODS: A retrospective cohort study was performed using patient-specific Health Care Financing Administration data to evaluate a random 5 percent sample of all Medicare patients who underwent surgery in 1993. Of these, 18,912 patients had an index abdominal procedure. Two-year follow-up data documented outcomes of hospitalizations with obstruction, adhesiolysis for obstruction, and/or additional open colorectal or general surgery. RESULTS: Within two years of incision, excision, and anastomosis of intestine (International Classification of Diseases (ICD)-9 code 45), 14.3 percent of patients had obstructions, 2.6 percent required adhesiolysis for obstructions, and 12.9 percent underwent additional open colorectal or general surgery. After other operations of intestine (ICD code 46), 17 percent of patients had obstructions, 3.1 percent required adhesiolysis for obstructions, and 20.2 percent underwent additional open colorectal or general surgery. After operations of rectum, rectosigmoid, and perirectal tissue (ICD code 48), 15.3 percent of patients had obstructions, 5.1 percent required adhesiolysis for obstructions, and 16.4 percent underwent additional open colorectal or general surgery. After other operations on the abdominal region (ICD code 54), 12.4 percent of patients had obstructions, 2.3 percent required adhesiolysis for obstructions, and 8.8 percent underwent additional open colorectal or general surgery. CONCLUSIONS: In this retrospective study of Medicare patients, we learned that bowel obstruction, adhesiolysis for obstructions, and additional abdominal surgery occurred more often after abdominal surgery than was previously published.

Postpolypectomy colonic hemorrhage

PURPOSE: This study was undertaken to evaluate the incidence, diagnostic methods, and treatment of hemorrhage occurring after colonoscopic polypectomy. METHODS: A retrospective chart review was conducted of 12,058 patients who underwent colonoscopy at an academic referral center between January 1989 and July 1993. Of these, 6,365 patients required polypectomies or biopsies. RESULTS: After these procedures, 13 patients (0.2 percent) developed lower gastrointestinal hemorrhage requiring hospitalization. All bleeding episodes occurred within 12 days of polypectomy or biopsy (mean=8 days). Twelve patients (92 percent) underwent technetium-tagged red blood cell scintigraphy, which localized bleeding in four patients (31 percent). In the eight patients with normal scintigrams, hemorrhage did not recur, and no further evaluation was performed. Five patients (38 percent) underwent arteriography. Arteriogram was positive in two of four patients with positive scintigrams, and bleeding was controlled with selective vasopressin infusion. The fifth patient had arteriography without prior diagnostic studies because of massive hemorrhage; the bleeding site was identified and controlled with selective vasopressin infusion. Three patients had lower gastrointestinal endoscopy, with endoscopic identification of bleeding site in two patients, and endoscopic electrocautery controlled the bleeding in one patient. In the 13 patients with hemorrhage, cessation of bleeding occurred with intestinal rest and hydration in nine patients (69 percent), selective vasopressin infusion in three patients (23 percent), and endoscopic electrocautery in one patient (8 percent). Eight patients (62 percent) required blood transfusion with a mean of 4.8 units (excluding one patient on warfarin sodium who required 14 units of blood). No patient required surgical intervention. CONCLUSIONS: Incidence of hemorrhage after colonoscopic polypectomy or biopsy is low, and in our series, hemorrhage resolved without the need for surgical intervention. Management includes initial stabilization followed by diagnostic evaluation. Technetium-tagged red blood cell nuclear scintigraphy identifies ongoing bleeding and identifies patients in whom additional invasive procedures (arteriography, lower gastrointestinal tract endoscopy) are warranted.

Effect of previous surgery on abdominal opening time.

PURPOSE: The purpose of this study was to document prospectively the time required to gain access to the abdomen to perform a planned procedure in patients with and without previous surgery. METHODS: Patients were obtained from the consecutive cases of 11 surgeons at three colorectal surgery centers. Opening time (skin incision to retractor placement) was measured and recorded in the operating room by the circulating nurse or by an independent researcher. Demographic data including the number and type of previous operations and the presence and severity of adhesions were recorded by the staff surgeon. A comparison of opening times between patients with and without previous abdominal operations was conducted. RESULTS: One hundred ninety-eight patients had abdominal operations. Fifty-five percent had previous abdominal procedures. Patients with prior surgery required a mean of 21 minutes to open their abdomens, whereas patients without prior surgery required a mean of 6 minutes (P<0.01). The median times were 17 and 6 minutes, respectively. Eighty-three percent of patients with prior surgery had adhesions, whereas only 7 percent of patients had adhesions on their initial operation. Patients with prior surgery also had higher grade adhesions (P<0.001). Irrespective of previous surgery, comparing patients with adhesions with those without, patients with adhesions required a mean of 22 minutes to open, whereas the lack of adhesions resulted in a mean opening time of 6 minutes. CONCLUSIONS: Previous surgery and the presence of adhesions add significant time to opening the abdomen.

Predictive value of technetium Tc 99m-labeled red blood cell scintigraphy for positive angiogram in massive lower gastrointestinal hemorrhage

PURPOSE: This study was performed to evaluate whether the time interval from injection of technetium Tc 99m (99mTc)-labeled red blood cells to the time of a radionuclide “blush” (positive scan) can be used to improve the efficacy in predicting a positive angiogram. METHOD: A retrospective review revealed 160 patients who received99mTc-labeled red blood cell scintigraphy for evaluation of massive lower gastrointestinal hemorrhage between 1989 and 1994. Patients were included who demonstrated signs of shock on admission, had an initial decrease in hematocrit of ≥6 percent, or required a minimum transfusion of two units of packed red blood cells. Scanning duration was 90 minutes, with imaging every 2 minutes. Time interval from injection to a positive scan was analyzed to determine predictability of a positive angiography. RESULTS: Of 160 patients, 86 demonstrated positive scans, of whom 47 underwent angiography. These 47 patients were divided into two groups according to scan results. Group 1 (n = 33) had immediate appearance of blush; Group 2 (n = 14) had blush after two minutes. In Group 1, 20 of 33 patients had a positive angiogram, yielding a positive predictive value of 60 percent (P = 0.033). Of the 14 patients with negative angiograms (13 from Group 1, and 1 with a negative scan), 6 had radiographic occlusion of the inferior mesenteric artery and 1 had spasm of the right colic artery, with scans that blushed in the respective distributions. Excluding these seven patients yielded a positive predictive value of 75 percent (P = 0.0072) for angiography. In patients with a delayed blush (Group 2), 13 of 14 had negative angiograms, yielding a negative predictive value of 93 percent (92 percent excluding those with nonvisualization of the inferior mesenteric artery). Twenty of 21 (95 percent) positive angiograms occurred in Group 1 patients. Of the 27 patients with negative angiograms, 13 were Group 2 patients. CONCLUSION: Patients with immediate blush on99mTc-labeled red blood cell scintigraphy required urgent angiography. Patients with delayed blush have low angiographic yields. These data suggest that patients with delayed blush or negative scans may be observed and evaluated with colonoscopy.

Fecal seepage and soiling: A problem of rectal sensation

PURPOSE: To determine the physiologic alteration resulting in fecal seepage and soiling, results of anorectal manometric testing were evaluated in patients with varying degrees of fecal incontinence. METHODS: Anal manometric studies performed on 170 patients with fecal incontinence were reviewed. Results of their studies, including mean resting pressure, maximum resting pressure, maximum squeezing pressure, minimum rectal sensory volume, and minimum volume at which reflex relaxation first occurs, were compared with those of 35 control group subjects with normal fecal continence. Manometric studies were performed using a four-channel, water-perfused catheter. Incontinent patients were divided into three groups based on presenting complaints: complete incontinence (incontinence of gas and liquid and solid stool), partial incontinence (incontinence of gas and liquid), and seepage and soiling (incontinence of small amounts of liquid and solid stool without immediate awareness). RESULTS: Resting pressures were significantly lower in complete incontinence, partial incontinence, and seepage and soiling groups than in the controls (P<0.001). Resting pressures of the complete incontinence group were also significantly lower than those of the partial incontinence and seepage and soiling groups (P=0.03). Squeezing pressures were lower for both the complete incontinence and partial incontinence groups than for those in the control group (P<0.001) and in the seepage and soiling group, which did not differ significantly from controls. The minimum rectal sensory volume was greater in all incontinent groups than in controls (P<0.001). Sensory volume of the seepage and soiling group was significantly greater than that of the complete incontinence and partial incontinence groups (P<0.01). The difference between sensory volume and the volume producing reflex relaxation was greatest in the seepage and soiling group and differed from that of the partial incontinence and control groups. CONCLUSIONS: These findings suggest that the mechanism of incontinence is different in seepage and soiling patients and involves a dyssynergy of rectal sensation and anal relaxation. Patients with the pattern of seepage and soiling may be successfully treated with stool bulking agents (e.g.,psyllium or bran).

Treatment of colorectal and ileoanal anastomotic sinuses

PURPOSE: This study is designed to describe a technique and report results for treating low anastomotic sinuses. METHODS: Restorative proctocolectomy and complicated low anterior resections were protected with diverting loop ileostomy. Contrast enemas identified anastomotic problems before ileostomy closure. Pouch-anal or colorectal anastomotic sinuses that failed to resolve with observation were treated before intestinal continuity was restored. With the patient receiving regional or general anesthesia, a rigid proctoscope or anoscope was used to identify the sinus opening. The common wall between the sinus and the bowel lumen was divided under direct vision with laparoscopic cautery scissors, and the sinus cavity was debrided with a suction cautery wand placed through the scope. RESULTS: Six patients with anastomotic sinuses have received outpatient treatment in the described manner during the past two years. Four patients had restorative proctocolectomies for ulcerative colitis, and two had low anastomosis for rectal cancer. Three patients presented with pelvic sepsis before the contrast study; the remainder were asymptomatic. Division of anastomotic sinus was performed one to eight months after diagnosis of the sinus. Following division, anastomotic cavities resolved in five patients by 1 month and in one patient by 12 months. In these six patients, there was one dilatable anastomotic stricture but no other anastomotic complications at follow-up 5 to 16 (mean, 9.2) months after sinus division. CONCLUSION: When used in conjunction with fecal diversion, sinus unroofing by division of the common wall between the sinus and bowel lumen treats low pelvic sinuses.

Diminutive colonic polyps: An indication for colonoscopy

A prospective study investigated the significance of solitary diminutive colonic polyps discovered during screening flexible sigmoidoscopy. Eighty-two patients with a solitary diminutive polyp (≤5 mm) underwent colonoscopy after cold biopsy of the index polyp. Of the patients with adenomatous index polyps, 42.5 percent had proximal neoplastic polyps. Of the patients with hyperplastic index polyps, proximal neoplastic polyps were found in 38.9 percent. These data suggest that diminutive polyps identified during flexible sigmoidoscopy, whether adenomatous or hyperplastic, place the patient in the intermediate risk group for colorectal neoplasia. We recommend that any patient with polyps seen during screening sigmoidoscopy, regardless of histopathology, should undergo colonoscopy.

Colon surveillance after colorectal cancer surgery.

PURPOSE: This study was performed to determine costeffective colonoscopy guidelines for patients with prior colorectal adenocarcinoma. METHOD: A retrospective review was performed of patients who had been treated for colorectal adenocarcinoma and later underwent follow-up colonoscopy from 1984 to 1994. RESULTS: During this study period, 389 patients previously treated for colorectal adenocarcinoma underwent follow-up colonoscopy. All patients had perioperative colon evaluation for other neoplasms. Ages ranged from 26 to 89 (mean, 65.8) years, and 46.8 percent were female. Recurrent or metachronous cancer or a neoplastic polyp constituted a positive examination. Results of 389 first follow-up colonoscopies were compared with 259 second (66.6 percent), 165 third (42.4 percent), and 83 fourth (21.3 percent) follow-up examinations. Median interval between all colonoscopies was 13 months. Positive examination rates for the first two yearly examinations were 18.3 and 18.5 percent, respectively. Slightly lower, third-year and fourth-year positive examination rates were 16.4 and 14.5 percent, respectively. Fouryear examinations yielded the following: first year-1 carcinoid, 1 new adenocarcinoma, and 100 polyps; second year-1 anastomotic recurrence and 68 polyps; third year-55 polyps; and fourth year-1 recurrent cancer and 17 polyps. CONCLUSIONS: These data suggest that 1) annual follow-up colonoscopy for two years after colorectal cancer surgery is beneficial for detecting recurrent and metachronous neoplasms and 2) the interval between subsequent examinations may be increased depending on the result of the most recent examination.

Long-term survival after treatment of malignant colonic polyps.

PURPOSE: This study was designed to evaluate the long-term outcome and survival of patients treated for malignant colonic polyps. METHODS: A retrospective review of 15,975 cases of colonoscopies with 8,685 endoscopic polypectomies performed between 1972 and 1990 was undertaken. In 65 patients, the polypectomy specimens contained invasive carcinoma. Six patients were excluded (follow-up, <6 months). Polyp data, operative findings, and follow-up on the remaining 59 patients were recorded. RESULTS: Malignant polyps were found in 35 males and 24 females who had an average age of 64 (range, 39–81) years. Follow-up ranged from 12 to 202 (mean, 90) months. Tumor differentiation was poor in one and well or moderately differentiated in 58 patients. Positive or indeterminate margins were found in 13 patients. Thirty-seven (63 percent) patients were managed with polypectomy and surveillance. Four of these (with rectal tumors) also had an additional local excision for questionable margins. One recurrence was noted in a patient who refused surgery, which was recommended because of indeterminate margins. Twenty-two patients (37 percent) underwent colectomy. Indications included Haggitt Level 3 or 4 invasion (19), inadequate margins (7), patient preference (1), and poor differentiation (1). Residual disease was found in colectomy specimens of three patients (14 percent). There were no cancer-related deaths in either treatment group. Life table analysis demonstrated a five-year survival of 82 percent for the colectomy group and 95 percent for the polypectomy group (P=0.15). CONCLUSION: Treatment of patients with malignant polyps must be individualized based on evolving criteria. Patients in whom polypectomy margins are inadequate should undergo colectomy. With appropriate selection criteria, patients selected for colectomy had a five-year survival rate similar to the rate of those treated by polypectomy alone.