手工缝合与吻合器缝合法关闭回肠袢式造口术的比较：HASTA 试验：一项随机对照试验的研究方案和设计。

Hand-suture versus stapling for closure of loop ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial.

机构信息

Department of General, Visceral and Transplantation Surgery, University of Heidelberg, Germany.

出版信息

Trials. 2011 Feb 8;12:34. doi: 10.1186/1745-6215-12-34.

DOI:10.1186/1745-6215-12-34

PMID:21303515

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC3042950/

Abstract

BACKGROUND

Colorectal cancer is the second most common tumor in developed countries, with a lifetime prevalence of 5%. About one third of these tumors are located in the rectum. Surgery in terms of low anterior resection with mesorectal excision is the central element in the treatment of rectal cancer being the only option for definite cure. Creating a protective diverting stoma prevents complications like anastomotic failure and meanwhile is the standard procedure. Bowel obstruction is one of the main and the clinically and economically most relevant complication following closure of loop ileostomy. The best surgical technique for closure of loop ileostomy has not been defined yet.

METHODS/DESIGN: A study protocol was developed on the basis of the only randomized controlled mono-center trial to solve clinical equipoise concerning the optimal surgical technique for closure of loop ileostomy after low anterior resection due to rectal cancer.The HASTA trial is a multi-center pragmatic randomized controlled surgical trial with two parallel groups to compare hand-suture versus stapling for closure of loop ileostomy. It will include 334 randomized patients undergoing closure of loop ileostomy after low anterior resection with protective ileostomy due to rectal cancer in approximately 20 centers consisting of German hospitals of all level of health care. The primary endpoint is the rate of bowel obstruction within 30 days after ileostomy closure. In addition, a set of surgical and general variables including quality of life will be analyzed with a follow-up of 12 months. An investigators meeting with a practical session will help to minimize performance bias and enforce protocol adherence. Centers are monitored centrally as well as on-site before and during recruitment phase to assure inclusion, treatment and follow up according to the protocol.

DISCUSSION

Aim of the HASTA trial is to evaluate the efficacy of hand-suture versus stapling for closure of loop ileostomy in patients with rectal cancer.

TRIAL REGISTRATION

German Clinical Trial Register Number: DRKS00000040.

摘要

背景

结直肠癌是发达国家第二常见的肿瘤，其终生患病率为 5%。这些肿瘤约有三分之一位于直肠。低位前切除术加中直肠切除术是治疗直肠癌的核心要素，是明确治愈的唯一选择。创建保护性转流造口可预防吻合口失败等并发症，同时是标准程序。肠阻塞是回肠造口关闭后主要的、也是临床上和经济上最相关的并发症之一。尚未定义回肠造口关闭的最佳手术技术。

方法/设计：基于唯一的随机对照单中心试验，制定了研究方案，以解决因直肠癌而行低位前切除术后保护性回肠造口关闭的最佳手术技术的临床均衡问题。HASTA 试验是一项多中心实用随机对照手术试验，有两个平行组，比较手工缝合与吻合器缝合用于闭合保护性回肠造口的疗效。它将包括大约 20 个中心的 334 名随机患者，这些患者因直肠癌而行保护性回肠造口术，然后进行低位前切除术。主要终点是回肠造口关闭后 30 天内的肠阻塞发生率。此外，还将分析一组手术和一般变量，包括生活质量，并进行 12 个月的随访。一次研究者会议和实践课程将有助于最大限度地减少操作偏差并加强方案依从性。在招募阶段之前和期间，中央和现场都会对中心进行监测，以确保根据方案进行纳入、治疗和随访。