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Application of Adcon-P or Seprafilm in consecutive laparotomies using a murine model

Oncel, Mustafa; Remzi, Feza H; Senagore, Anthony J; Connor, Jason T; Fazio, Victor W
BACKGROUND: Intraabdominal administration of antiadhesive products may reduce postoperative adhesions. We compared two barriers, Adcon-P (Gliatech, Cleveland, Ohio) and Seprafilm (Genzyme, Cambridge, Massachusetts), in a relaparotomy murine model to evaluate whether using them during the first and second laparotomy reduces adhesion formation better than using them only during the relaparotomy. METHODS: One-hundred and fifty mice underwent cecal abrasion, followed by complete adhesiolysis and cecal abrasion 21 days later. All were sacrified 21 days after the second operation. The mice (30 to a group) received Adcon-P in both surgeries (AA), Seprafilm in both surgeries (SS), Adcon-P in the second surgery (CA), Seprafilm in the second surgery (CS), or neither barrier (CC). Difficulty of adhesiolysis was blindly assessed with a 6-point scoring system and sites of adhesions were determined with a yes/no questionnaire. RESULTS: The AA group had lower adhesiolysis score than SS, CS, and CC groups, and had fewer adhesions over cecum and between cecum and intra-peritoneal fat than all other groups. The numbers of the animals had adhesions between the cecum and abdominal wall were similar between the treatment groups. No difference was observed between SS and CS groups in any analysis. CONCLUSIONS: Using Adcon-P starting with the first laparotomy more effectively reduce adhesion formation and difficulty of adhesiolysis. Using Seprafilm only in the relaparotomy is as effective as using it in both laparotomies. Adcon-P is more effective in preventing adhesions to different sites than Seprafilm except to the abdominal wall under the midline incision.
PMID: 14769326
ISSN: 0002-9610
CID: 2156862

Complications of ileoanal pouches

Gorgun, Emre; Remzi, Feza H
Restorative proctocolectomy with ileal pouch-anal anastomosis is the surgical therapy of choice for patients with chronic ulcerative colitis and the majority of patients with familial adenomatous polyposis. It restores gastrointestinal continuity, re-establishes transanal defecation, and avoids a permanent stoma. Although this technically demanding procedure is associated with low mortality rates, it is frequently accompanied by early and late complications. This article will review these complications and discuss the interventions that are needed to provide appropriate treatment.
PMCID:2780072
PMID: 20011284
ISSN: 1530-9681
CID: 2156872

Functional outcome and quality of life after repeat ileal pouch-anal anastomosis for complications of ileoanal surgery

Baixauli, Jorge; Delaney, Conor P; Wu, James S; Remzi, Feza H; Lavery, Ian C; Fazio, Victor W
PURPOSE: Disconnection of an ileal pouch-anal anastomosis with repeat ileal pouch-anal anastomosis has been proposed for treatment of ileal pouch-anal anastomosis failure caused by septic or functional complications. We report our experience with repeat ileal pouch-anal anastomosis, and document functional outcome and quality of life. METHODS: Of 101 patients undergoing laparotomy, ileoanal disconnection, and repeat ileal pouch-anal anastomosis, 80 were referred from other institutions. Indications included: chronic anastomotic leak (n=27), perineal or pouch-vaginal fistula (n=47), anastomotic stricture (n=22), dysfunction/long efferent limb of S-pouch (n=36), and previous ileal pouch-anal anastomosis excision or exclusion (n=6). In 64 cases a "septic" indication was observed. Pathologic features of Crohn's disease were present in 4 patients preoperatively and 15 more after repeat ileal pouch-anal anastomosis. Four patients had clinical features of Crohn's disease. RESULTS: Three patients had no ileostomy, and 82 patients had temporary ileostomy closure. Of these, 82 percent have a functioning pouch, with a median follow-up of 32 functioning months. Two were rediverted and 13 had the pouch excised. Five-year pouch survival was 74 percent, higher for ulcerative colitis (79 percent) than Crohn's disease (53 percent; P=0.06). No differences were seen between those having repeat ileal pouch-anal anastomosis for septic or nonseptic indications, or whether using a new or repaired pouch. Patients defecated 6.3 +/- 2.8 (mean +/- standard deviation) times per day, and 2 +/- 1.9 per night. Thirty-five percent of patients never described urgency. Fecal seepage occurred in 50 percent during the day and 69 percent at night. Using the Cleveland Global Quality of Life Score to assess the patient's quality of life, health, level of energy, and happiness with surgery (each scored from 0-10), quality of life was 8.2 +/- 1.6, and happiness with surgery was 9 +/- 2. Ninety-seven percent would undergo repeat ileal pouch-anal anastomosis again, and 99 percent would recommend it to others. CONCLUSIONS: Repeat ileal pouch-anal anastomosis is a valid alternative for patients with ileal pouch-anal anastomosis failure. A controlled septic condition should not preclude salvage surgery. Although pouch failure occurs more frequently than after primary ileal pouch-anal anastomosis, patient satisfaction and quality of life are high.
PMID: 14719144
ISSN: 0012-3706
CID: 2156882

A cost-effectiveness analysis of diagnostic strategies for symptomatic patients with ileal pouch-anal anastomosis

Shen, Bo; Shermock, Kenneth M; Fazio, Victor W; Achkar, Jean-Paul; Brzezinski, Aaron; Bevins, Charles L; Bambrick, Marlene L; Remzi, Feza H; Lashner, Bret A
OBJECTIVE: Pouchitis is often diagnosed based on symptoms and empirically treated with antibiotics (treat-first strategy). However, symptom assessment alone is not reliable for diagnosis, and an initial evaluation with pouch endoscopy (test-first strategy) has been shown to be more accurate. Cost-effectiveness of these strategies has not been compared. The aim of this study was to compare cost-effectiveness of different clinical approaches for patients with symptoms suggestive of pouchitis. METHODS: Pouchitis was defined as pouchitis disease activity index scores > or =7. The frequency of pouchitis in symptomatic patients with ileal pouch was estimated to be 51%; the efficacy for initial therapy with metronidazole (MTZ) and ciprofloxacin (CIP) was 75% and 85%, respectively. Cost estimates were obtained from Medicare reimbursement data. RESULTS: Six competing strategies (MTZ trial, CIP trial, MTZ-then-CIP trial, CIP-then-MTZ trial, pouch endoscopy with biopsy, and pouch endoscopy without biopsy) were modeled in a decision tree. Costs per correct diagnosis with appropriate treatment were $194 for MTZ trial, $279 for CIP trial, $208 for MTZ-then-CIP trial, $261 for CIP-then-MTZ trial, $352 for pouch endoscopy with biopsy, and $243 for pouch endoscopy without biopsy. Of the two strategies with the lowest cost, the pouch endoscopy without biopsy strategy costs $50 more per patient than the MTZ trial strategy but results in an additional 15 days for early diagnosis and thus initiation of appropriate treatment (incremental cost-effectiveness ratio $3 per additional day gained). The results of base-case analysis were robust in sensitivity analyses. CONCLUSIONS: Although the MTZ-trial strategy had the lowest cost, the pouch endoscopy without biopsy strategy was most cost-effective. Therefore, based on its relatively low cost and the avoidance of both diagnostic delay and adverse effects associated with unnecessary antibiotics, pouch endoscopy without biopsy is the recommended strategy among those tested for the diagnosis of pouchitis.
PMID: 14638349
ISSN: 0002-9270
CID: 2156892

Liquid antiadhesive product (Adcon-p) prevents post-operative adhesions within the intra-abdominal organs in a rat model

Oncel, Mustafa; Remzi, Feza H; Senagore, Anthony J; Connor, Jason T; Fazio, Victor W
BACKGROUND AND AIMS: Postoperative adhesions mostly cleave to small bowel and lead to troublesome problems. This study evaluated the effectiveness of a novel liquid antiadhesive product (Adcon-P) in rats. SUBJECTS AND METHODS: Thirty-eight Sprague Dawley rats underwent laparotomy during which the surgeon created abrasions on five different small bowel locations and the cecum in order to generate adhesions. Rats were randomly assigned to receive Adcon-P ( n=19) or to a control group ( n=19). The animals were killed on postoperative day 21. An observer blinded to the randomization assessed the difficulty of adhesiolysis with a six-point scoring system, recorded locations of adhesions and, noted the presence of serosal and full-thickness injuries. The total number of adhesions was also chronicled. RESULTS: The severity of adhesion and adhesion scores were significantly lower in animals receiving Adcon-P. More animals suffered full-thickness and serosal injuries in the control group. The adhesions between small bowel segments and the number of adhesions attached to the small bowel were significantly lower in animals that received Adcon-P. CONCLUSION: Adcon-P leads to an easier adhesiolysis and lessens the risk of bowel injury during relaparotomy. In particular, Adcon-P reduces the probability that adhesions specifically attach to the small bowel.
PMID: 12827407
ISSN: 0179-1958
CID: 2156952

Quantification of risk for pouch failure after ileal pouch anal anastomosis surgery

Fazio, Victor W; Tekkis, Paris P; Remzi, Feza; Lavery, Ian C; Manilich, Elena; Connor, Jason; Preen, Miriam; Delaney, Conor P
OBJECTIVE: To identify risk factors associated with ileal pouch failure and to develop a multifactorial model for quantifying the risk of failure in individual patients. SUMMARY BACKGROUND DATA Ileal pouch anal anastomosis (IPAA) has become the treatment choice for most patients with ulcerative colitis and familial adenomatous polyposis who require surgery. At present, there are no published studies that investigate collectively the interrelation of factors related to ileal pouch failure, nor are there any predictive indices for risk stratification of patients undergoing IPAA surgery. METHODS: Data from 23 preoperative, 7 intraoperative, and 10 postoperative risk factors were recorded from 1,965 patients undergoing restorative proctocolectomy in a single center between 1983 and 2001. Primary end point was ileal pouch failure during the follow-up period of up to 19 years. The "CCF ileal pouch failure" model was developed using a parametric survival analysis and a 70%:30% split-sample validation technique for model training and testing. RESULTS: The median patient follow-up was 4.1 year (range, 0-19 years). Five-year ileal pouch survival was 95.6% (95% CI, 94.4-96.7). The following risk factors were found to be independent predictors of pouch survival and were used in the final multivariate model: patient diagnosis, prior anal pathology, abnormal anal manometry, patient comorbidity, pouch-perineal or pouch-vaginal fistulae, pelvic sepsis, anastomotic stricture and separation. The model accurately predicted the risk of ileal pouch failure with adequate calibration statistics (Hosmer Lemeshow chi2 = 3.001; P = 0.557) and an area under the receiver operating characteristics curve of 82.0%. CONCLUSIONS: The CCF ileal pouch failure model is a simple and accurate way of predicting the risk of ileal pouch failure in clinical practice on a longitudinal basis. It may play an important role in providing risk estimates for patients wishing to make informed choices on the type of treatment offered to them.
PMCID:1360119
PMID: 14530732
ISSN: 0003-4932
CID: 2156902

Anal transitional zone cancer after restorative proctocolectomy and ileoanal anastomosis in familial adenomatous polyposis: report of two cases [Case Report]

Ooi, Boon Swee; Remzi, Feza H; Gramlich, Terry; Church, James M; Preen, Miriam; Fazio, Victor W
PURPOSE: Restorative proctocolectomy with ileal pouch-anal anastomosis is accepted as the surgical treatment of choice for many patients with familial adenomatous polyposis. The risk of cancer developing in the ileal pouch after this surgery is unknown. Cancer may arise from the ileal pouch after restorative proctocolectomy, but that arising from the anal transitional zone has not been documented in familial adenomatous polyposis. We report two cases of this cancer from the anal transitional zone in patients with familial adenomatous polyposis, with a review of the literature. METHODS: All patients with familial adenomatous polyposis treated with restorative proctocolectomy and ileal pouch-anal anastomosis in The Cleveland Clinic were included in the study. Patients whose surveillance biopsy of the anal transitional zone revealed invasive adenocarcinoma were studied. RESULTS: Among a total of 146 patients with familial adenomatous polyposis who underwent restorative proctocolectomy and ileal pouch-anal anastomosis from 1983 to 2001 in our institution, none developed cancer of the anal transitional zone at up to 18 years of follow-up. However, there were two patients, both of whom underwent surgery elsewhere but who were followed up here, who developed invasive adenocarcinoma of the anal transitional zone. In one of them, cancer was diagnosed three years after a double-stapled ileal pouch-anal anastomosis, whereas in the other, cancer occurred eight years after a straight ileoanal anastomosis with mucosectomy. CONCLUSIONS: Cancer may develop in the anal transitional zone after restorative proctocolectomy with ileal pouch-anal anastomosis for familial adenomatous polyposis. Long-term surveillance of the anal transitional zone needs to be emphasized.
PMID: 14530685
ISSN: 0012-3706
CID: 2156912

Prospective, age-related analysis of surgical results, functional outcome, and quality of life after ileal pouch-anal anastomosis

Delaney, Conor P; Fazio, Victor W; Remzi, Feza H; Hammel, Jeff; Church, James M; Hull, Tracy L; Senagore, Anthony J; Strong, Scott A; Lavery, Ian C
OBJECTIVE To evaluate how age affects functional outcome and quality of life after ileal pouch anal anastomosis (IPAA). SUMMARY BACKGROUND DATA Because of the limited number of older patients undergoing IPAA, it has been difficult to assess functional outcome and quality of life stratified by age. METHODS IPAA was performed in 1895 patients. Patients were stratified by age into <45 (n = 1410), 46-55 (n = 289), 56-65 (n = 154), and more than 65 years (n = 42). Outcome was assessed prospectively. Results are presented at 1, 3, 5, and 10 years after surgery.RESULTS Patients were followed for 4.6 +/- 3.7 years (maximum, 17 years). Pouch failure occurred in 4.1% (pouch excision or permanent diversion). Incontinence and night time seepage were more common in older patients. There were minor differences in the quality of life, health, energy and happiness between age groups, with a slight benefit for those under 45 years. Fourteen percent or fewer patients experienced social, sexual or work restrictions. Overall, 96% of patients were happy to have undergone their surgery, and 98% recommended it to others. Although the respective figures were 89% and 96% in the over-65 age group, the difference was not significant. CONCLUSIONS These data provide a unique assessment of outcome after IPAA at multiple time points. Although functional outcome after IPAA is not as good in older patients, appropriate case selection confers acceptable function and quality of life to patients of all ages.
PMCID:1422678
PMID: 12894015
ISSN: 0003-4932
CID: 2156922

Management and treatment outcome of pouch-vaginal fistulas following restorative proctocolectomy

Shah, Nishit S; Remzi, Feza; Massmann, Arndt; Baixauli, Jorge; Fazio, Victor W
PURPOSE: The purpose of the study was to evaluate the outcome of surgical management of pouch-vaginal fistulas in females who had undergone restorative proctocolectomy. METHODS: This study was designed as a retrospective chart review of females treated for pouch-vaginal fistulas from 1983 to 2000. All patients were followed up using our prospective pouch registry, with additional data collected by interview or mailed questionnaire. RESULTS: Sixty females were identified (mean age, 33.3 +/- 1.3 years), of whom 33 had their initial restorative proctocolectomy done at our institution. Preoperative diagnosis was ulcerative colitis (88 percent), indeterminate colitis (10 percent), and familial adenomatous polyposis (2 percent). Average time to pouch-vaginal fistula following restorative proctocolectomy was 21 months (range, 1-132 months). Postoperative pelvic sepsis had occurred in 17 (28 percent) patients. Primary treatment modalities included the following: local repairs (n = 46, 77 percent), the majority of which were ileal advancement flaps; redo restorative proctocolectomy (n = 6, 10 percent); and pouch excision (n = 5, 8 percent). Initial healing was achieved in 20 patients. An additional 11 patients with recurrences healed after repeat procedures. The overall healing rate was 52 percent at 49.4 +/- 3.8 months follow-up. Pouch failure was the eventual outcome in 13 (22 percent) patients and 16 (27 percent) patients had persistent pouch-vaginal fistula. A delayed diagnosis of Crohn's disease was made in 24 patients. Crohn's disease patients had lower success rates following ileal advancement flaps compared with the non-Crohn's group (25 vs. 48 percent, respectively), much lower overall healing rates of their pouch-vaginal fistulas (17 vs. 75 percent, respectively), and a higher incidence of pouch failure (33 vs. 14 percent, respectively). CONCLUSION: Pouch-vaginal fistulas are a difficult problem in females following restorative proctocolectomy. However, local repair can be successful with good functional outcomes. Redo restorative proctocolectomy may also achieve healing if local repairs are not possible or have failed. A delayed diagnosis of Crohn's disease results in worse treatment outcome and higher pouch failure rates.
PMID: 12847365
ISSN: 0012-3706
CID: 2156932

Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection

Delaney, Conor P; Zutshi, Massarat; Senagore, Anthony J; Remzi, Feza H; Hammel, Jeffrey; Fazio, Victor W
INTRODUCTION: In an era of dwindling hospital resources and increasing medical costs, safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare resources. Although several protocols have been reported to reduce postoperative stay, no Level I evidence exists for their use in routine clinical practice. METHODS: Sixty-four patients undergoing laparotomy and intestinal or rectal resection were randomly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care. Time to discharge from hospital, complication and readmission rates, pain level, quality of life, and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery. Subgroups were defined to evaluate those who derived the optimal benefit from the protocol. RESULTS: Pathway patients spent less total time in the hospital after surgery (5.4 vs. 7.1 days; P = 0.02) and less time in the hospital during the primary admission than traditional patients. Patients younger than 70 years old had greater benefits than the overall study group (5 vs. 7.1 days; P = 0.01). Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway (P = 0.01). There was no difference between pathway and traditional patients for readmission or complication rates, pain score, quality of life after surgery, or overall satisfaction with the hospital stay. CONCLUSIONS: Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet. Pathway patients have a shorter hospital stay, with no adverse effect on patient satisfaction, pain scores, or complication rates. Patients younger than 70 years of age derive the optimal benefit, and increased surgeon experience improves outcome.
PMID: 12847356
ISSN: 0012-3706
CID: 2156942