Smedh Kenneth, Sverrisson Ingvar, Chabok Abbas, Nikberg Maziar
Colorectal Unit, Department of Surgery and Centre for Clinical Research, Uppsala University, Västmanland's Hospital Västerås, 721 89, Västerås, Sweden.
BMC Surg. 2016 Jul 11;16(1):43. doi: 10.1186/s12893-016-0161-2.
The use of Hartmann's procedure in the old and frail and/or in patients with fecal incontinence is increasing, even though some data have reported high postoperative rates of pelvic abscesses. Abdominoperineal excision with intersphincteric dissection has been proposed as a better alternative and is performed increasingly both nationally and internationally. However, no studies have been performed to support this. The aim of this study is to randomize patients between Hartmann's procedure and abdominoperineal excision with intersphincteric dissection and compare post-operative surgical morbidity and quality of life. The hypothesis is that intersphincteric abdominoperineal excision provides less pelvic and perineal morbidity.
METHODS/DESIGN: In this multicentre randomized controlled study, Hartmann's procedure will be compared with intersphincteric abdominoperineal excision in patients with rectal cancer unsuitable for an anterior resection. The patients are operated in different ways around the ano-rectum, otherwise the same procedure is performed with total mesorectal excision and all will receive a colostomy. The one-month postoperative control will focus on post-operative surgical complications, especially the perineal-pelvic, reoperations and other interventions. After one year, late complications such as pain in the perineal or pelvic area or disorders such as secretion or bleeding from the anorectal stump will be recorded and a follow-up of quality of life performed. Histological and oncological data will also be recorded, the latter up to 5 years post-operatively.
The HAPIrect trial is the first randomized controlled trial comparing standard low Hartmann's procedure with intersphincteric abdominoperineal excision in patients with rectal cancer with the aim of categorizing the post-operative surgical morbidity.
ClinicalTrials.gov Identifier: NCT01995396 . Date of registration November 25, 2013.
尽管有数据报道Hartmann手术在老年体弱和/或大便失禁患者中的盆腔脓肿术后发生率较高，但该手术的使用仍在增加。腹会阴切除术联合括约肌间分离术已被提议作为一种更好的替代方法，并且在国内和国际上的实施越来越多。然而，尚无研究支持这一点。本研究的目的是将患者随机分为Hartmann手术组和腹会阴切除术联合括约肌间分离术组，比较术后手术并发症及生活质量。假设是括约肌间腹会阴切除术可减少盆腔和会阴部的并发症。
方法/设计：在这项多中心随机对照研究中，将对不适合前切除术的直肠癌患者比较Hartmann手术和括约肌间腹会阴切除术。患者围绕肛门直肠进行不同方式的手术，否则采用相同的全直肠系膜切除术，所有患者均接受结肠造口术。术后1个月的对照将重点关注手术并发症，尤其是会阴 - 盆腔并发症、再次手术及其他干预措施。1年后，记录会阴或盆腔区域疼痛等晚期并发症或肛门直肠残端分泌物或出血等病症，并对生活质量进行随访。还将记录组织学和肿瘤学数据，后者随访至术后5年。
HAPIrect试验是第一项比较标准低位Hartmann手术与括约肌间腹会阴切除术治疗直肠癌患者的随机对照试验，目的是对术后手术并发症进行分类。
ClinicalTrials.gov标识符：NCT01995396。注册日期：2013年11月25日。
