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 | Completed

• 1 other identifier: XHEC-C-2023-022-2
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

ileostomy; complications; NOSES; stoma suture

Outcome Measures

Primary Outcomes (1)

• Complication rate of stoma

  Observe and assess for stoma complications

  Within one month after surgery

Secondary Outcomes (3)

• Stoma DET（Discoloration，Erosion and Tissue overgrowth） score

  Within one month after surgery

• Stoma Pain Score

  Within one month after surgery

• Quality of life scale score for patients with stoma

  Day 30 after surgery

Study Arms (2)

"Dumpling suture" for ileostomy

EXPERIMENTAL

The stoma is fixed with sutures in a skin fold method, and the incision is progressively reduced in a process similar to the process of folding and pinching the Chinese small dumplings. This procedure may reduce stoma complications by progressively reducing the incision and realizing the effect of hiding the skin incision.

Procedure: Suturing of ileostomy using "Dumpling suture method"

Traditional suture for ileostomy

OTHER

The stoma was fixed at the skin using traditional sutures. The incision is narrowed by 2-3 interrupted sutures at the distal and proximal ends of the skin incision on the abdominal wall. The stoma is then fixed at the right lower abdominal incision with sutures.

Procedure: Suturing of ileostomy using Traditional suture method

Interventions

Suturing of ileostomy using "Dumpling suture method" PROCEDURE

Suturing of ileostomy using "Dumpling suture method"

"Dumpling suture" for ileostomy

Suturing of ileostomy using Traditional suture method PROCEDURE

Suturing of ileostomy using Traditional suture method

Traditional suture for ileostomy

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for rectal anterior resection surgery with specimen extraction via stoma
• No serious systemic infection or immunosuppression
• Patients aged above 18 years and below 100 years
• Eastern Cooperative Oncology Group Performance Status: 0-1
• Expected survival time \> 6 months
• Patient participate voluntarily and sign an informed consent form

You may not qualify if:

• Patients who do not require a prophylactic stoma after preoperative evaluation
• Any skin infectious disease of the abdominal wall
• Surgery less than 1 month from the last chemotherapy
• Previously underwent any other stoma surgery
• Presence of a serious active or uncontrollable infection requiring systemic therapy
• Previous history of definite neurological or psychiatric disorders
• Patient may not be able to complete the study for other reasons, or who the investigator believes should not be included

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, 200092, China

Location

Study Officials

• Tingyu Wu, Doctor

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 3, 2023
• First Posted: August 14, 2023
• Study Start: March 21, 2023
• Primary Completion: October 6, 2024
• Study Completion: December 31, 2024
• Last Updated: April 30, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR

Locations

CN (1)