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NCT06344923 Clinical Trial

Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

Rectal Neoplasms Clinical Trial

Official title:
Does Suturing the Peritoneum and Anterior Rectus Sheath Affect the Safety of Temporary Loop Ileostomy After Laparoscopic Anterior Rectal Resection

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT06344923
Other study ID # KYLL
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2024
Est. completion date September 1, 2025

Study information
Verified date March 2024
Source Qilu Hospital of Shandong University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 120
Est. completion date September 1, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - preventive ileostomy in laparoscopic rectal surgery Exclusion Criteria: - ileostomy due to anastomotic leak

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Qilu Hospital of Shandong University

Outcome
Type Measure Description Time frame Safety issue
Primary postoperative complications related to ileostomy after primary surgery to ileostomy closure (6 months after primary surgery)
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