Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

NCT06344923 | Recruiting

• 1 other identifier: KYLL
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Ileostomy - Stoma; Rectal Neoplasms

Outcome Measures

Primary Outcomes (1)

• postoperative complications related to ileostomy

  after primary surgery to ileostomy closure (6 months after primary surgery)

Study Arms (2)

modified preventive ileostomy

EXPERIMENTAL

Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing

Procedure: Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing

conventional preventive ileostomy

ACTIVE COMPARATOR

Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Procedure: Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing

Interventions

Ileostomy with a support rod instead of the layer of peritoneum and anterior rectus sheath suturing PROCEDURE

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. A support rod, made of a 24# silicone drainage tube with a 1ml syringe was passed through the mesentery of the small intestine. The support rod was removed two weeks after surgery. It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches.

modified preventive ileostomy

Ileostomy with the layer of the peritoneum and anterior rectus sheath suturing PROCEDURE

The terminal ileum about 30cm proximal to the cecum was recognized and was lifted out of the body through the auxiliary incision at the right lower abdomen and made sure that the ileum was not twisted. Appropriate sutures can be used to narrow the peritoneal incision, preferably by inserting one finger. The seromuscular layer of the ileum or the mesentery was intermittently sutured with peritoneum and the anterior sheath of the rectus abdominis circumferentially with 8-10 stitches (3-0 silk thread). It is appropriate that the ileum wall protruded from the epidermis by about 3cm. After suturing trocar sites, the loop ileostomy was opened along the longitudinal axis of the intestinal wall, and 4-0 absorbable suture was used to fix the stoma and subcutaneous tissue circumferentially with 16-20 stitches

conventional preventive ileostomy

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• preventive ileostomy in laparoscopic rectal surgery

You may not qualify if:

• ileostomy due to anastomotic leak

Sponsors & Collaborators

• Qilu Hospital of Shandong University: lead

Study Sites (1)

Qilu Hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

MeSH Terms

Conditions

Rectal Neoplasms

Interventions

Ileostomy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Enterostomy; Digestive System Surgical Procedures; Surgical Procedures, Operative; Ostomy

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2024
• First Posted: April 3, 2024
• Study Start: May 14, 2024
• Primary Completion: May 31, 2025
• Study Completion: September 1, 2025
• Last Updated: October 16, 2024

Record last verified: 2024-03

Locations

CN (1)