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单孔腹腔镜与多孔腹腔镜结直肠手术的比较:一项多中心、双盲、随机对照临床试验。

Single-incision Laparoscopy Versus Multiport Laparoscopy for Colonic Surgery: A Multicenter, Double-blinded, Randomized Controlled Trial.

机构信息

Colorectal Surgery Department, Hôpital Beaujon, Assistance Publique-Hôpitaux de Paris, University Paris VII, Clichy, France.

Department of Digestive Surgery, CHU Rouen, Rouen University, Rouen, France.

出版信息

Ann Surg. 2018 Nov;268(5):740-746. doi: 10.1097/SLA.0000000000002836.

DOI:10.1097/SLA.0000000000002836
PMID:30303873
Abstract

OBJECTIVE

To compare outcome of single-port laparoscopy (SPL) and multiport laparoscopy (MPL) laparoscopy for colonic surgery.

SUMMARY OF BACKGROUND DATA

Benefits of SPL over MPL are yet to be demonstrated in large randomized trials.

METHODS

In this prospective, double-blinded, superiority trial, patients undergoing laparoscopic colonic resection for benign or malignant disease were randomly assigned to SPL or MPL (NCT01959087). Primary outcome was length of theoretical hospital stay (LHS).

RESULTS

One hundred twenty-eight patients were randomized and 125 analyzed: 62 SPL and 63 MPL, including 91 right (SPL: n = 44, 71%; MPL: n = 47, 75%) and 34 left (SPL: n = 18, 29%; MPL: n = 16, 25%) colectomies, performed for Crohn disease (n = 53, 42%), cancer (n = 36, 29%), diverticulitis (n = 21, 17%), or benign neoplasia (n = 15, 12%). Additional port insertion was required in 5 (8%) SPL patients and conversion to laparotomy occurred in 7 patients (SPL: n = 3, 5%; MPL: n = 4, 7%; P = 1.000). Total length of skin incision was significantly shorter in the SPL group [SPL: 56 ± 41 (range, 30-300) mm; MPL: 87 ± 40 (50-250) mm; P < 0.001]. Procedure duration, intraoperative complication rate, postoperative 30-day morbidity, postoperative pain, and time to first bowel movement were similar between the groups, leading to similar theoretical LHS (SPL: 6 ± 3 days; MPL: 6 ± 2; P = 0.298). At 6 months, quality of life was similar between groups, but patients from the SPL group were significantly more satisfied with their scar aspect than patients from the MPL group (P = 0.003).

CONCLUSION

SPL colectomy does not confer any additional benefit other than cosmetic result, as compared to MPL.

摘要

目的

比较单孔腹腔镜(SPL)与多孔腹腔镜(MPL)在结肠手术中的疗效。

背景资料概要

SPL 相对于 MPL 的优势仍有待于大样本随机对照试验来证实。

方法

本前瞻性、双盲、优效性试验纳入了因良性或恶性疾病而接受腹腔镜结肠切除术的患者,将其随机分配至 SPL 或 MPL 组(NCT01959087)。主要结局为理论住院时间(LHS)的长短。

结果

共 128 例患者被随机分组,125 例患者被纳入分析:62 例 SPL 和 63 例 MPL,包括 91 例右半结肠切除术(SPL:n = 44,71%;MPL:n = 47,75%)和 34 例左半结肠切除术(SPL:n = 18,29%;MPL:n = 16,25%),病因分别为克罗恩病(n = 53,42%)、癌症(n = 36,29%)、憩室炎(n = 21,17%)和良性肿瘤(n = 15,12%)。5 例 SPL 患者需要额外插入辅助操作孔,7 例患者中转开腹(SPL:n = 3,5%;MPL:n = 4,7%;P = 1.000)。SPL 组的总皮肤切口长度显著更短[SPL:56 ± 41(范围:30-300)mm;MPL:87 ± 40(50-250)mm;P < 0.001]。两组的手术时间、术中并发症发生率、术后 30 天发病率、术后疼痛和首次排气时间均无显著差异,导致理论 LHS 相似(SPL:6 ± 3 天;MPL:6 ± 2 天;P = 0.298)。6 个月时,两组的生活质量相似,但 SPL 组患者对手术瘢痕外观的满意度显著高于 MPL 组(P = 0.003)。

结论

与 MPL 相比,SPL 结肠切除术除了美容效果之外,并没有带来任何额外的益处。

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