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Clinical Conference Prevention of postoperative abdominal adhesions by a novel, glycerol/sodium hyaluronate/carboxymethylcellulose-based bioresorbable membrane: a prospective, randomized, evaluator-blinded multicenter study. 2005
Cohen Z, Senagore AJ, Dayton MT, Koruda MJ, Beck DE, Wolff BG, Fleshner PR, Thirlby RC, Ludwig KA, Larach SW, Weiss EG, Bauer JJ, Holmdahl L. · Department of Surgery, Mount Sinai Hospital, University of Toronto, Toronto, Canada. · Dis Colon Rectum. · Pubmed #15868230 No free full text.
Abstract: INTRODUCTION: Postoperative abdominal adhesions are associated with significant morbidity and mortality, placing a substantial burden on healthcare systems worldwide. Development of a bioresorbable membrane containing up to 23 percent glycerol and chemically modified sodium hyaluronate/carboxymethylcellulose offers ease of handling and has been shown to provide significant postoperative adhesion prevention in animals. This study was designed to assess the safety of glycerol hyaluronate/carboxymethylcellulose and to evaluate its efficacy in reducing the incidence, extent, and severity of postoperative adhesion development in surgical patients. METHODS: Twelve centers enrolled 120 patients with ulcerative colitis or familial polyposis who were scheduled for a restorative proctocolectomy and ileal pouch-anal anastomosis with diverting loop ileostomy. Before surgical closure, patients were randomized to no anti-adhesion treatment (control) or treatment with glycerol hyaluronate/carboxymethylcellulose membrane under the midline incision. At ileostomy closure, laparoscopy was used to evaluate the incidence, extent, and severity of adhesion formation to the midline incision. RESULTS: Data were analyzed using the intent-to-treat population. Treatment with glycerol hyaluronate/carboxymethylcellulose resulted in 19 of 58 patients (33 percent) with no adhesions compared with 6 of 60 adhesion-free patients (10 percent) in the no treatment control group (P = 0.002). The mean extent of postoperative adhesions to the midline incision was significantly lower among patients treated with glycerol hyaluronate/carboxymethylcellulose compared with patients in the control group (P < 0.001). The severity of postoperative adhesions to the midline incision was significantly less with glycerol hyaluronate/carboxymethylcellulose than with control (P < 0.001). Adverse events were similar between treatment and no treatment control groups with the exception of abscess and incisional wound complications were more frequently observed with glycerol hyaluronate/carboxymethylcellulose. CONCLUSIONS: Glycerol hyaluronate/carboxymethylcellulose was shown to effectively reduce adhesions to the midline incision and adhesions between the omentum and small bowel after abdominal surgery. Safety profiles for the treatment and no treatment control groups were similar with the exception of more infection complications associated with glycerol hyaluronate/carboxymethylcellulose use. Animal models did not predict these complications.
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Article Perioperative blood transfusions increase infectious complications after ileoanal pouch procedures (IPAA). 2006
Madbouly KM, Senagore AJ, Remzi FH, Delaney CP, Waters J, Fazio VW. · Department of Surgery, University of Alexandria, Alexandria, Egypt. · Int J Colorectal Dis. · Pubmed #16583193 No free full text.
Abstract: BACKGROUND AND PURPOSE: Assessment of risk factors associated with the use of perioperative allogeneic blood transfusion and the effect of transfusion on infectious complications after ileal pouch-anal anastomosis (IPAA). METHODS: All patients included had IPAA with ileostomy. They were divided into two groups: transfused (TRAN); nontransfused (NON). Data included age, gender, preoperative anemia (Hgb <9 l g/dl), operative blood loss, transfusion volume, incidence of postoperative infectious or anastomotic complications, and length of stay (LOS). RESULTS: The 1,202 patients eligible for the study were divided into: TRAN = 240 patients and NON = 962 patients. The patient age, sex, and preoperative steroid use were similar in both groups. Significantly, more patients in the TRAN group were anemic preoperatively (32 vs 11%; p<0.05) and the preoperative Hgb level was significantly lower in the TRAN (12.07; p<0.05 vs 13.34 g/dl). Transfusion was required more frequently in anemic patients (p<0.001). The overall infection rate was significantly higher in the TRAN (48.75 vs 11.22%, p<0.001), Anastomotic separation (10.83 vs 3.32%, TRAN and NON, respectively; p<0.001) and fistula formation percentage (20.8 vs 4.46%, TRAN and NON, respectively; p<0.001) was significantly higher in the TRAN group. Pelvic sepsis also occurred more frequent in TRAN (22.9 vs 4.2%, TRAN and NON, respectively; p<0.001). The incidence of any infectious complication at any site was higher in anemic patients irrespective of transfusion status (18.2 vs 2.8%, p<0.05). Transfusion was the only significant independent risk factor for postoperative infections. LOS was adversely affected by an infectious complication (9 vs 7 days, p<0.001). CONCLUSIONS: Preoperative anemia is a significant risk factor for perioperative transfusion with significant increase in postoperative infectious complications and anastomotic complications after IPAA. Strategies to correct preoperative anemia, refine indications for transfusion, and define the use of blood salvage techniques may be helpful in decreasing this risk.
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Article Analysis of the outcome of ileal pouch-anal anastomosis in patients with Crohn's disease. 2004
Hartley JE, Fazio VW, Remzi FH, Lavery IC, Church JM, Strong SA, Hull TL, Senagore AJ, Delaney CP. · Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Dis Colon Rectum. · Pubmed #15622572 No free full text.
Abstract: PURPOSE: Ileal pouch-anal anastomosis has come to represent the procedure of choice for patients requiring surgery for mucosal ulcerative colitis. In contrast, a proven diagnosis of Crohn's disease is generally held to preclude ileal pouch-anal anastomosis. However, patients with ileal pouch-anal anastomosis for apparent mucosal ulcerative colitis who are subsequently found to have Crohn's disease have a variable course. We reviewed our experience in this scenario to determine whether selected patients with Crohn's disease may be candidates for ileal pouch-anal anastomosis. METHODS: A retrospective review of the prospectively maintained ileal pouch-anal anastomosis database was undertaken to identify patients with a diagnosis of Crohn's disease after ileal pouch-anal anastomosis. Clinical outcome and quality-of-life data were obtained from the database and chart review. End points were the development of recrudescent Crohn's disease, pouch failure, and quality of life and functional outcome at the time of data collection. Differences between groups were calculated using the chi-squared test. Cumulative incidence of recrudescent Crohn's disease and pouch loss were calculated by the Kaplan-Meier method. Factors predictive of development of recrudescent Crohn's disease and pouch loss were examined by univariate analysis. RESULTS: Sixty patients (32 females; median age, 33 (range, 15-74) years) who underwent ileal pouch-anal anastomosis for mucosal ulcerative colitis subsequently had that diagnosis revised to Crohn's disease. Median follow-up of all patients was 46 (range, 4-158) months at time of data collection by which time 21 patients (35 percent) had developed recrudescent Crohn's disease. No pre-ileal pouch-anal anastomosis factors examined were predictors of the development of recrudescent Crohn's disease on univariate analysis. Median follow-up of the latter group was 63 (range, 0-132) months from time of diagnosis, by which time six patients underwent pouch excision and another patient was permanently defunctioned. The overall pouch loss rate for the entire cohort was 12 percent and 33 percent for those with recrudescent Crohn's disease. Median daily bowel movements in those with ileal pouch-anal anastomosis in situ at the time of data collection was 7 (range, 3-20), with 50 percent of patients rarely or never experiencing urgency and 59 percent reporting perfect or near perfect continence. Median quality of life, health, and happiness scores were 9.9 and 10 of 10. CONCLUSIONS: The secondary diagnosis of Crohn's disease after ileal pouch-anal anastomosis is associated with protracted freedom from clinically evident Crohn's disease, low pouch loss rate, and good functional outcome. Such results only can be improved by the continued development of medical strategies for the long-term suppression of Crohn's disease. These data support a prospective evaluation of ileal pouch-anal anastomosis in selected patients with Crohn's disease.
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Article Clinical outcome and factors predictive of recurrence after enterocutaneous fistula surgery. free! 2004
Lynch AC, Delaney CP, Senagore AJ, Connor JT, Remzi FH, Fazio VW. · Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, OH 44195, USA. · Ann Surg. · Pubmed #15492564 links to free full text
Abstract: OBJECTIVE: Recent experience with surgery for enterocutaneous fistulae (ECF) at a specialist colorectal unit is reviewed to define factors relating to a successful surgical outcome. SUMMARY BACKGROUND DATA: ECF cause significant morbidity and mortality and need experienced surgical management. Previous publications have concentrated on mortality resulting from fistulae, while factors affecting recurrence have not previously been a focus of analysis. METHODS: Records were reviewed of patients who had ECF surgery (1994-2001). Management strategy involved early drainage of sepsis and nutritional support prior to elective ECF repair, with selective defunctioning proximal stoma formation. RESULTS: A total of 205 patients were available (89 males, 43%; median age, 51 years; range, 16-86) years). ECF were related to Crohn's disease in 95, ulcerative colitis in 18, diverticular disease in 17, carcinoma in 25 (16 after radiotherapy), mesh ventral hernia repair in 21, and other causes in 29. Forty-one (20%) had undergone attempted fistula repair at other institutions. Initial management included CT-guided drainage of an intra-abdominal abscess in 23 patients, and total parenteral nutrition in 74 (36%). A total of 203 patients had definitive ECF repair. Forty-four had oversewing or wedge resection of the fistula, and 159 had resection and reanastomosis of the involved small bowel segment or ileocolic anastomosis. Ninety-day operative mortality was 3.5%. A total of 42 (20.5%) patients developed ECF recurrence within 3 months. Multivariate analysis demonstrated that recurrence was more likely after oversewing (36%) than resection (16%, P = 0.006). CONCLUSIONS: A strategy of drainage of acute sepsis, maintenance of nutritional support prior to surgery, and selective use of PS allows for primary closure in 80% of complicated ECF. Resection should be performed when feasible.
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Article Prospective assessment of Cleveland Global Quality of Life (CGQL) as a novel marker of quality of life and disease activity in Crohn's disease. 2003
Kiran RP, Delaney CP, Senagore AJ, O'Brien-Ermlich B, Mascha E, Thornton J, Fazio VW. · Department of Colorectal Surgery, Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Am J Gastroenterol. · Pubmed #12907333 No free full text.
Abstract: OBJECTIVES: The Short Form 36 (SF-36) questionnaire is the most widely accepted measure of quality of life (QOL); however, it is cumbersome to use and requires complicated analysis. The Cleveland Global Quality of Life (CGQL) is a simpler tool, which has been validated in patients with ulcerative colitis undergoing restorative proctocolectomy. This study validates CGQL in patients with Crohn's disease and determines the correlation of QOL measurement systems with disease activity as measured by the Crohn's Disease Activity Index (CDAI). METHODS: All patients with Crohn's disease presenting to this department between September 2001 and February 2002 were prospectively entered into a database, including demographic data, disease manifestations, Vienna classification, age at diagnosis, and duration of Crohn's disease. SF-36, CGQL, and CDAI scores were entered concurrently. Cronbach's alpha was used to assess the internal consistency among the components of the CGQL score. Correlation among various QOL measures was assessed with Spearman's test. Relationships between QOL measures and various baseline factors were assessed by Wilcoxon rank sum test, Student's t test, Kruskal-Wallis test, and Pearson's test, depending on the type and distribution of data. Change from baseline in the CGQL was assessed with the Wilcoxon signed rank test. RESULTS: One hundred seventy-eight (178) patients were entered into the database, and 169 completed QOL and CDAI data. There was a significant correlation between SF-36 and CGQL. CGQL and SF-36 correlated similarly with CDAI. Neither patient age, gender, or smoking history were associated with CGQL. CONCLUSIONS: CGQL correlates with disease activity and is a simple measure of QOL in Crohn's disease.
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Article Prospective, age-related analysis of surgical results, functional outcome, and quality of life after ileal pouch-anal anastomosis. free! 2003
Delaney CP, Fazio VW, Remzi FH, Hammel J, Church JM, Hull TL, Senagore AJ, Strong SA, Lavery IC. · Departments of *Colorectal Surgery. · Ann Surg. · Pubmed #12894015 links to free full text
Abstract: 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.
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Article Urgent colectomy in a patient with membranous tracheal disruption after severe vomiting. free! 2000
Irefin SA, Farid IS, Senagore AJ. · Departments of General Anesthesiology and Colorectal Surgery, The Cleveland Clinic Foundation, Cleveland, Ohio 44195, USA. · Anesth Analg. · Pubmed #11049926 links to free full text
Abstract: Implications: We report a case of a patient who developed membranous tracheal disruption after severe vomiting. He subsequently required urgent colectomy for toxic megacolon under general anesthesia. With this challenging situation, we were able to successfully conduct general anesthesia in the presence of tracheal laceration, pneumothorax, and pneumomediastinum.
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