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Trial Title:
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
NCT ID:
NCT05627284
Condition:
Stoma Site Incisional Hernia
Conditions: Official terms:
Hernia
Incisional Hernia
Conditions: Keywords:
Stoma Site Incisional Hernia
Colon cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Prevention
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Stoma reversal with bio-mesh placement
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.
Arm group label:
Stoma reversal with bio-mesh placement
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.
Criteria for 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).
Gender:
All
Minimum age:
18 Years
Maximum age:
75 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Nanjing Drum Tower Hospital
Address:
City:
Nanjing
Zip:
210000
Country:
China
Status:
Recruiting
Contact:
Last name:
Meilin Jiang, Dr.
Phone:
+86 025-68182923
Email:
gyethics@163.com
Start date:
October 1, 2022
Completion date:
September 30, 2025
Lead sponsor:
Agency:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Agency class:
Other
Source:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05627284
