Peritoneum and Anterior Rectus Sheath Suturing and Ileostomy

October 13, 2024 updated by: Qilu Hospital of Shandong University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250012
        • Recruiting
        • Qilu Hospital of Shandong University
        • Contact:
        • Principal Investigator:
          • Xiang Zhang, M.D. Ph.D
        • Sub-Investigator:
          • Yanlei Wang, M.D. Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • preventive ileostomy in laparoscopic rectal surgery

Exclusion Criteria:

  • ileostomy due to anastomotic leak

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: modified preventive ileostomy
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
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.
Active Comparator: conventional preventive ileostomy
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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
postoperative complications related to ileostomy
Time Frame: after primary surgery to ileostomy closure (6 months after primary surgery)
after primary surgery to ileostomy closure (6 months after primary surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

September 1, 2025

Study Registration Dates

First Submitted

March 24, 2024

First Submitted That Met QC Criteria

March 31, 2024

First Posted (Actual)

April 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 16, 2024

Last Update Submitted That Met QC Criteria

October 13, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KYLL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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