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

Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School (Other)
Overall Status
Recruiting
CT.gov ID
NCT05627284
Collaborator
(none)
58
Enrollment
1
Location
1
Arm
36
Anticipated Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Stoma reversal with bio-mesh placement
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
58 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Actual Study Start Date :
Oct 1, 2022
Anticipated Primary Completion Date :
Sep 30, 2024
Anticipated Study Completion Date :
Sep 30, 2025

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. stoma site incisional hernia [one-year after surgery]

    Hernia occurs on the primary stoma site

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Nanjing Drum Tower Hospital Nanjing Jiangsu China 210000

Sponsors and Collaborators

  • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
ClinicalTrials.gov Identifier:
NCT05627284
Other Study ID Numbers:
  • 2022-LCYJ-PY-33
First Posted:
Nov 25, 2022
Last Update Posted:
Nov 25, 2022
Last Verified:
Oct 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Stoma Site Incisional Hernia
Colon cancer
Additional relevant MeSH terms:
Hernia
Incisional Hernia

Study Results

No Results Posted as of Nov 25, 2022