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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

NCT05985499 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-04-30

No results posted yet for this study

Summary

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.

Conditions

  • Ileostomy; Complications

Interventions

PROCEDURE

Suturing of ileostomy using "Dumpling suture method"

Suturing of ileostomy using "Dumpling suture method"

PROCEDURE

Suturing of ileostomy using Traditional suture method

Suturing of ileostomy using Traditional suture method

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Tingyu Wu, Doctor · Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-21
Primary Completion
2024-10-06
Completion
2024-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05985499 on ClinicalTrials.gov