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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

Study Description
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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
Stoma Site Incisional Hernia Procedure: Stoma reversal with bio-mesh placement Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : October 1, 2022
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : September 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Arms and Interventions
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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
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Primary Outcome Measures :
  1. stoma site incisional hernia [ Time Frame: one-year after surgery ]
    Hernia occurs on the primary stoma site


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05627284


Contacts
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Contact: Yonghuan Mao, Dr +86 15151877330 maoyonghuan@163.com

Locations
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China, Jiangsu
Nanjing Drum Tower Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Meilin Jiang, Dr.    +86 025-68182923    gyethics@163.com   
Sponsors and Collaborators
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
More Information
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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: November 25, 2022    Key Record Dates
Last Update Posted: November 25, 2022
Last Verified: October 2022

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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:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes