纤维蛋白胶预防腹腔镜胃旁路术后吻合口漏和内疝的临床评估：一项前瞻性、随机多中心试验的初步结果

Clinical evaluation of fibrin glue in the prevention of anastomotic leak and internal hernia after laparoscopic gastric bypass: preliminary results of a prospective, randomized multicenter trial.

作者信息

Silecchia G, Boru C E, Mouiel J, Rossi M, Anselmino M, Tacchino R M, Foco M, Gaspari A L, Gentileschi P, Morino M, Toppino M, Basso N

机构信息

Dipartmento di Chirurgia Generale Paride Stefanini, Policlinico Umberto I, University of Rome La Sapienza, Rome, Italy.

出版信息

Obes Surg. 2006 Feb;16(2):125-31. doi: 10.1381/096089206775565249.

DOI:10.1381/096089206775565249

PMID:16469211

Abstract

BACKGROUND

Gastro-jejunal anastomotic leak and internal hernia can be life-threatening complications of laparoscopic Roux-en-Y gastric bypass (LRYGBP), ranging from 0.1-4.3% and from 0.8-4.5% respectively. The safety and efficacy of a fibrin glue (Tissucol) was assessed when placed around the anastomoses and over the mesenteric openings for prevention of anastomotic leaks and internal hernias after LRYGBP.

METHODS

A prospective, randomized, multicenter, clinical trial commenced in January 2004. Patients with BMI 40-59 kg/m2, aged 21-60 years, undergoing LRYGBP, were randomized into: 1) study group (fibrin glue applied on the gastro-jejunal and jejuno-jejunal anastomoses and the mesenteric openings); 2) control group (no fibrin glue, but suture of the mesenteric openings). 322 patients, 161 for each arm, will be enrolled for an estimated period of 24 months. Sex, age, operative time, time to postoperative oral diet and hospital stay, early and late complications rates are evaluated. An interim evaluation was conducted after 15 months.

RESULTS

To April 2005, 204 patients were randomized: 111 in the control group (mean age 39.0+/-11.6 years, BMI 46.4 +/- 8.2) and 93 in the fibrin glue group (mean age 42.9+/-11.7 years, BMI 46.9+/-6.4). There was no mortality or conversion in both groups; no differences in operative time and postoperative hospital stay were recorded. Time to postoperative oral diet was shorter for the fibrin glue group (P = 0.0044). Neither leaks nor internal hernias have occurred in the fibrin glue group. The incidence of leaks (2 cases, 1.8%) and the overall reoperation rate were higher in the control group (P=0.0165).

CONCLUSION

The preliminary results suggest that Tissucol application has no adverse effects, is not time-consuming, and may be effective in preventing leaks and internal hernias in morbidly obese patients undergoing LRYGBP.

摘要

背景

胃空肠吻合口漏和内疝是腹腔镜Roux-en-Y胃旁路术（LRYGBP）可能危及生命的并发症，发生率分别为0.1%-4.3%和0.8%-4.5%。评估了一种纤维蛋白胶（Tissucol）在吻合口周围和肠系膜开口处使用时预防LRYGBP术后吻合口漏和内疝的安全性和有效性。

方法

一项前瞻性、随机、多中心临床试验于2004年1月开始。体重指数（BMI）为40-59kg/m²、年龄21-60岁且接受LRYGBP的患者被随机分为：1）研究组（在胃空肠和空肠空肠吻合口以及肠系膜开口处应用纤维蛋白胶）；2）对照组（不使用纤维蛋白胶，但缝合肠系膜开口）。预计将招募322例患者，每组161例，为期24个月。评估性别、年龄、手术时间、术后开始经口进食的时间和住院时间、早期和晚期并发症发生率。15个月后进行中期评估。

结果

至2005年4月，204例患者被随机分组：对照组111例（平均年龄39.0±11.6岁，BMI 46.4±8.2），纤维蛋白胶组93例（平均年龄42.9±11.7岁，BMI 46.9±6.4）。两组均无死亡或中转开腹情况；手术时间和术后住院时间无差异。纤维蛋白胶组术后开始经口进食的时间较短（P = 0.0044）。纤维蛋白胶组未发生吻合口漏和内疝。对照组的吻合口漏发生率（2例，1.8%）和总体再次手术率较高（P = 0.0165）。