A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH

November 16, 2022 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

The goal of this clinical trial is to explore the safety and effectiveness of stoma reversal combining bio-mesh placement in patients with high risk of stoma site incisional hernia (SSIH). The main questions it aims to answer are:

  • Whether bio-mesh placement is safe for patients with a high risk of SSIH.
  • Whether stoma reversal combining bio-mesh placement is a preventive strategy for patients with high risk of SSIH.
  • Whether stoma reversal combining bio-mesh placement will trigger other complications.

Participants who are eligible and are enrolled in this study will receive stoma reversal combining bio-mesh placement surgery. After that, they will be followed up for one year to evaluate the occurrence of SSIH and other complications.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

58

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 Contact

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Drum Tower Hospital
        • Contact:

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age: 18-75 years old;
  • Patients should have colonic prophylactic stoma and have not received reversal yet;
  • There are no obvious signs of tumor recurrence or metastasis in tumor patients before stoma resection;
  • No serious underlying diseases, can tolerate general anesthesia surgery
  • Preoperative ECOG (Eastern Cooperative Oncology Group) physical status score 0/1;
  • Preoperative ASA (American Society of Anesthesiologists) grade I-III;
  • Without vital organs function failure;
  • All patients and their families signed informed consent before surgery.

Exclusion Criteria:

  • Incapacitated persons;
  • With a history of other types of hernia;
  • Those who have had hernia mesh implantation before;
  • Those who are allergic to bio-mesh or their components before;
  • Combined with other surgeries;
  • Severe mental illness;
  • Severe respiratory disease;
  • Severe liver and kidney insufficiency;
  • Those who have absolute contraindications to surgery;
  • Suffering from severe bleeding disorders or obvious abnormal coagulation function;
  • History of unstable angina or myocardial infarction within 6 months;
  • History of cerebral infarction or cerebral hemorrhage within 6 months;
  • Continuous intravenous application of glucocorticoid within 1 month;
  • The patient has participated or is participating in other clinical studies (within 6 months).

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: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Stoma reversal with bio-mesh placement
Procedure: Stoma reversal with bio-mesh placement
Patients will receive stoma reversal. During the surgery, a bio-mesh is placed beyond the peritoneum on the surgical site to strengthen the abdominal wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
stoma site incisional hernia
Time Frame: one-year after surgery
Hernia occurs on the primary stoma site
one-year after surgery

Collaborators and Investigators

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

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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)

October 1, 2022

Primary Completion (Anticipated)

September 30, 2024

Study Completion (Anticipated)

September 30, 2025

Study Registration Dates

First Submitted

November 16, 2022

First Submitted That Met QC Criteria

November 16, 2022

First Posted (Actual)

November 25, 2022

Study Record Updates

Last Update Posted (Actual)

November 25, 2022

Last Update Submitted That Met QC Criteria

November 16, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-LCYJ-PY-33

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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