NCT05985499

A Randomized Parallel-controlled Study Comparing the Ileostomy "Dumpling Suture Method" With Traditional Suture Method in Rectal Anterior Resection Surgery With Specimen Extraction Via Stoma

Completed NA Last updated 30 April 2025

What this trial tests

NA trial testing Suturing of ileostomy using "Dumpling suture method" in Ileostomy; Complications in 72 participants. Completed in 31 December 2024.

Timeline

21 March 2023

Primary endpoint
6 October 2024

31 December 2024

Quick facts

Lead sponsor	Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	72
Start date	21 March 2023
Primary completion	6 October 2024
Estimated completion	31 December 2024
Sites	1 location across China

Drugs / interventions tested

• Suturing of ileostomy using "Dumpling suture method"
• Suturing of ileostomy using Traditional suture method

Conditions studied

• Ileostomy; Complications — all drugs for Ileostomy; Complications →

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Who can join

Adults 18 to 100, any sex, with Ileostomy; Complications. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Natural Orifice Specimen Extraction Surgery (NOSES), which involves obtaining specimens from the abdominal cavity without any incisions, has attracted much attention in recent years, and it has been widely popularized in the treatment of rectal cancer because of its postoperative non-incision, advantages of less trauma, quicker recovery, and postoperative aesthetics. Anastomotic fistula is a serious complication of rectal cancer surgery. For patients at high risk of anastomotic fistula, prophylactic ileostomy is often performed intraoperatively to divert feces and protect the anastomosis. For such patients, rectal anterior resection surgery with specimen extraction via stoma (NOSES with specimen extraction via stoma) is usually performed, borrowing a prophylactic stoma incision to retrieve the specimen, and also realizing the absence of additional abdominal incision. However, this procedure is prone to stoma infection and has a high complication rate (20-40%), which limits the popularization of NOSES surgery and is an urgent clinical problem. Our center has proposed a new stoma closure method (Dumpling Suture Method), which reduces the size of the incision by folding the suture to achieve the effect of hiding the skin incision and reduce stoma infection. In our previous study, 17 cases of the new procedure were completed in our center, and 25 patients with stoma closure by the traditional method were included in the same period for control purposes. After six months of follow-up, we found that the "dumpling suture method" significantly reduced the incidence of stoma complications compared with the traditional suture method (5.8% vs. 36%), and no additional adverse effects were observed. This is a single-center, open-label, randomized, parallel-controlled clinical study. The primary endpoint is stoma complication rate within 30 days postoperatively. In this study, we aim to evaluate the efficacy and safety of the "dumpling suture method " compared with the traditional stoma suture in reducing postoperative stoma complications through a randomized parallel controlled clinical trial, which is of great significance for the improvement of the rectal NOSES procedure and the reduction of the incidence of stoma complications.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Dumpling Suture Method Versus Traditional Suture Method of Diverting Loop Ileostomy in Laparoscopic Anterior Rectal Resection With Specimen Extraction Through Stoma Incision: A Randomized, Parallel-Controlled Trial.
   Liang Z, Gu J, Liu Y, Zhao Y, et al · · 2026 · PMID 41269064 · DOI 10.1097/dcr.0000000000004056