Department of Surgery, THG, Aarhus University Hospital, Denmark.
Department of Surgery, THG, Aarhus University Hospital, Denmark.
Lancet Gastroenterol Hepatol. 2016 Dec;1(4):291-297. doi: 10.1016/S2468-1253(16)30085-1. Epub 2016 Oct 4.
Laparoscopic ventral mesh rectopexy for rectal prolapse has been widely used over the past decade to reduce postoperative functional bowel disorders. We aimed to compare changes in functional outcome 12 months after laparoscopic ventral mesh rectopexy versus laparoscopic posterior sutured rectopexy in patients with rectal prolapse.
In this double-blind, randomised trial, consecutive patients aged 18 years or older at a single centre in Denmark with full-thickness rectal prolapse were randomly assigned (1:1) to either laparoscopic ventral mesh rectopexy or laparoscopic posterior sutured rectopexy by drawing numbers from opaque envelopes, in blocks of four for patients with or without preoperative constipation. Functional assessment was done preoperatively and 12 months postoperatively. The primary outcome was preoperative-to-postoperative change in obstructed defecation syndrome (ODS) score. Patients and those assessing the outcomes were masked to the procedure. The primary analysis was done in the per-protocol population. Safety outcomes were assessed in the entire cohort. The trial is registered with ClinicalTrials.gov, number NCT00946205.
From Nov 1, 2006, to Jan 31, 2014, 75 consecutive patients were assigned to laparoscopic posterior sutured rectopexy (n=37) or laparoscopic ventral mesh rectopexy (n=38). Eight patients withdrew consent to follow-up, leaving 34 patients in the posterior sutured rectopexy group and 33 in the ventral mesh rectopexy groups for the primary analysis. The preoperative-to-postoperative reduction in ODS score was 1·97 (95% CI 0·01 to 3·93) in patients who received ventral mesh rectopexy and 2·18 (-0·14 to 4·49) in those who received posterior sutured rectopexy (difference -0·21 [-3·19 to 2·78]; p=0·890). Postoperative surgical complications of Clavien-Dindo grade II or worse were reported in one (3%) of 38 patients in the ventral mesh rectopexy group (ureteral injury resulting in urine leakage, and a psoas abscess) and one (3%) of 37 patients in the posterior sutured rectopexy group (haematoma and pelvic abscess). Two (5%) patients in the posterior sutured rectopexy group developed recurrence within 12 months compared with none in the ventral mesh rectopexy group (p=0·305).
Functional outcome measured by preoperative-to-postoperative change in ODS score was not significantly superior in patients who underwent ventral mesh rectopexy compared with those who had posterior sutured rectopexy. Additional, large, randomised, multicentre studies with long-term outcomes are warranted.
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腹腔镜下经腹会阴直肠固定术（ventral mesh rectopexy）已广泛应用于直肠脱垂的治疗，以降低术后功能性肠道紊乱的发生。我们旨在比较腹腔镜下经腹会阴直肠固定术与腹腔镜下后吻合直肠固定术治疗直肠脱垂患者术后 12 个月时的功能性结局。
在这项单中心、双盲、随机试验中，丹麦的一个中心连续入组了年龄在 18 岁及以上的全层直肠脱垂患者，按 1:1 比例通过从不透明信封中抽取数字，以 4 例为一组，将患者随机分配至腹腔镜下经腹会阴直肠固定术或腹腔镜下后吻合直肠固定术组，分为伴有或不伴有术前便秘的两组。术前和术后 12 个月进行功能评估。主要结局为术前至术后梗阻性排便障碍综合征（obstructed defecation syndrome，ODS）评分的变化。患者和评估结局的人员对手术过程设盲。主要分析在符合方案人群中进行。在全队列中评估安全性结局。该试验在 ClinicalTrials.gov 注册，编号为 NCT00946205。
从 2006 年 11 月 1 日至 2014 年 1 月 31 日，共纳入 75 例连续患者，被分配至腹腔镜下后吻合直肠固定术（n=37）或腹腔镜下经腹会阴直肠固定术（n=38）组。8 例患者撤回随访同意，34 例患者（后吻合直肠固定术组）和 33 例患者（经腹会阴直肠固定术组）纳入主要分析。经腹会阴直肠固定术组的 ODS 评分从术前到术后降低 1.97（95%CI 0.01 至 3.93），后吻合直肠固定术组降低 2.18（-0.14 至 4.49）（差异-0.21[-3.19 至 2.78]；p=0.890）。经腹会阴直肠固定术组有 1 例（3%）（因输尿管损伤导致漏尿，和腰大肌脓肿）和后吻合直肠固定术组有 1 例（3%）（血肿和骨盆脓肿）发生 Clavien-Dindo 分级 II 级或更高级别的术后手术并发症。后吻合直肠固定术组有 2 例（5%）在 12 个月内复发，而经腹会阴直肠固定术组无一例复发（p=0.305）。
经腹会阴直肠固定术组患者的 ODS 评分从术前到术后的变化与后吻合直肠固定术组相比，其功能性结局并无显著改善。需要进一步开展更大规模、随机、多中心、长期随访的研究。
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