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腹腔镜乙状结肠切除术治疗憩室病与开放手术相比没有优势:一项随机对照试验的中期结果。

Laparoscopic sigmoid resection for diverticular disease has no advantages over open approach: midterm results of a randomized controlled trial.

机构信息

Department of General, Visceral, Vascular and Thoracic Surgery, Charité-University Medicine Berlin, Campus Mitte, Berlin, Germany.

出版信息

Langenbecks Arch Surg. 2011 Oct;396(7):973-80. doi: 10.1007/s00423-011-0825-4. Epub 2011 Jul 16.

Abstract

PURPOSE

Elective laparoscopic sigmoid resection (LSR) for symptomatic diverticular disease is supposed to have significant short-term advantages compared to open surgery (open sigmoid resection (OSR)). This opinion is rather based on inferences from trials on colonic resections for malignant diseases or minor laparoscopic surgery. This randomized controlled trial was conducted to compare quality of life as well as morbidity and clinical outcome after LSR vs. OSR following a midterm follow-up period.

METHODS

Patients presenting with a symptomatic sigmoid diverticular disease stage II/III (Stock/Hansen) were randomly allocated to LSR or OSR in a prospective multicenter trial. Endpoints included the quality of life assessed with a standardized questionnaire, postoperative mortality, and complications within the follow-up of 12 months after operation.

RESULTS

A total of 143 patients randomized between 2005 and 2008 in 12 centers could be analyzed. The recruitment was aborted for nonachievement of the planned sample size. Seventy-five patients were allocated to LSR, and 68 received OSR. Nine operations were converted to OSR (9%) and analyzed as intention to treat. Groups were comparable for age, gender, body mass index, comorbidity, and indication for surgery. Operation time was longer for LSR (p < 0.001). Quality of life did not differ between LSR and OSR, either during the early postoperative course or after 12 months (p = 0.172). Also, mortality and morbidity, including subgroups of major and minor morbidity, were compared.

CONCLUSION

LSR was not superior to OSR regarding postoperative quality of life and incidence of complications in this trial.

摘要

目的

与开腹手术(开腹乙状结肠切除术(OSR))相比,择期腹腔镜乙状结肠切除术(LSR)治疗症状性憩室病具有显著的短期优势。这种观点主要是基于对结肠切除术治疗恶性疾病或微创手术的试验推断得出的。本随机对照试验旨在比较 LSR 与 OSR 后的生活质量以及发病率和临床结果,并进行中期随访。

方法

本前瞻性多中心试验将有症状的乙状结肠憩室病 II/III 期(Stock/Hansen)患者随机分配至 LSR 或 OSR 治疗组。终点包括使用标准化问卷评估的生活质量、术后死亡率以及术后 12 个月内的并发症。

结果

在 2005 年至 2008 年期间,共有 143 名患者在 12 个中心随机分组,其中 75 名患者被分配至 LSR 组,68 名患者接受 OSR 治疗。9 例手术转为 OSR(9%)并进行意向治疗分析。两组在年龄、性别、体重指数、合并症和手术指征方面具有可比性。LSR 的手术时间较长(p<0.001)。LSR 和 OSR 组之间的生活质量在术后早期或 12 个月后均无差异(p=0.172)。同时还比较了死亡率和发病率,包括主要和次要发病率的亚组。

结论

在本试验中,LSR 并不优于 OSR,在术后生活质量和并发症发生率方面无差异。

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