Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

Not Applicable

Recruiting

• Conditions: Rectal Neoplasms; Ileostomy - Stoma
• Interventions: Procedure: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing; Procedure: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

• Registration Number: NCT06344923
• Lead Sponsor: Qilu Hospital of Shandong University

Brief Summary

In the era of laparoscopy, ileostomy via specimen extraction site has been proposed as a novel approach for temporary ostomy creation to prevent anastomotic leak after laparoscopic low anterior rectal resection. Whether suturing the layer of the peritoneum and anterior rectus sheath affects the safety of this novel approach has not been investigated.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-24
• Study First Submitted QC: 2024-03-31
• Study First Posted: 2024-04-03
• Study Start: 2024-05-14
• Last Update Submitted: 2024-10-13
• Last Update Posted: 2024-10-16
• Primary Completion: 2025-05-31
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• preventive ileostomy in laparoscopic rectal surgery

Exclusion Criteria

• ileostomy due to anastomotic leak

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
modified preventive ileostomy	Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing	Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing
conventional preventive ileostomy	Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing	Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Primary Outcome Measures

Name	Time	Method
postoperative complications related to ileostomy	after primary surgery to ileostomy closure (6 months after primary surgery)

Trial Locations

Locations (1)

Qilu Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China