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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05627284
Recruitment Status : Recruiting
First Posted : November 25, 2022
Last Update Posted : November 25, 2022
Sponsor:
Information provided by (Responsible Party):
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Tracking Information
First Submitted Date  ICMJE November 16, 2022
First Posted Date  ICMJE November 25, 2022
Last Update Posted Date November 25, 2022
Actual Study Start Date  ICMJE October 1, 2022
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 16, 2022)		 stoma site incisional hernia [ Time Frame: one-year after surgery ]
Hernia occurs on the primary stoma site
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Official Title  ICMJE A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Stoma Site Incisional Hernia
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Stoma reversal with bio-mesh placement
Intervention: Procedure: Stoma reversal with bio-mesh placement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 16, 2022)		 58
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 30, 2025
Estimated Primary Completion Date September 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Yonghuan Mao, Dr +86 15151877330 maoyonghuan@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05627284
Other Study ID Numbers  ICMJE 2022-LCYJ-PY-33
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Original Responsible Party Same as current
Current Study Sponsor  ICMJE The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP