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

Primary Purpose

Stoma Site Incisional Hernia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Stoma reversal with bio-mesh placement
Sponsored by
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Stoma Site Incisional Hernia focused on measuring Stoma Site Incisional Hernia, Colon cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Nanjing Drum Tower HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stoma reversal with bio-mesh placement

Arm Description

Outcomes

Primary Outcome Measures

stoma site incisional hernia
Hernia occurs on the primary stoma site

Secondary Outcome Measures

Full Information

First Posted
November 16, 2022
Last Updated
November 16, 2022
Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT05627284
Brief Title
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Official Title
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
September 30, 2024 (Anticipated)
Study Completion Date
September 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stoma Site Incisional Hernia
Keywords
Stoma Site Incisional Hernia, Colon cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stoma reversal with bio-mesh placement
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Stoma reversal with bio-mesh placement
Intervention Description
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.
Primary Outcome Measure Information:
Title
stoma site incisional hernia
Description
Hernia occurs on the primary stoma site
Time Frame
one-year after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yonghuan Mao, Dr
Phone
+86 15151877330
Email
maoyonghuan@163.com
Facility Information:
Facility Name
Nanjing Drum Tower Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Meilin Jiang, Dr.
Phone
+86 025-68182923
Email
gyethics@163.com

12. IPD Sharing Statement

Learn more about this trial

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

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