Surgery to reverse colostomy with bio-mesh to prevent hernias
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
This study is testing if using a special mesh during surgery to reverse a colostomy can help prevent hernias in patients who are at high risk.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 58 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05627284 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the safety and effectiveness of combining stoma reversal surgery with bio-mesh placement in patients at high risk for stoma site incisional hernia (SSIH). Participants aged 18-75 who have a colonic prophylactic stoma will undergo this surgical procedure and will be monitored for one year to assess the occurrence of SSIH and any potential complications. The study aims to determine if this combined approach can effectively prevent SSIH and if it poses any additional risks to patients.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a colonic prophylactic stoma who have not yet undergone reversal and meet specific health criteria.
Not a fit: Patients with a history of other hernias, severe underlying health conditions, or contraindications to surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of hernias in patients undergoing stoma reversal.
How similar studies have performed: While the specific combination of stoma reversal and bio-mesh placement is novel, similar approaches in hernia prevention have shown promise in other studies.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Nanjing, Jiangsu
- Nanjing Drum Tower Hospital — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Study coordinator: Yonghuan Mao, Dr
- Email: maoyonghuan@163.com
- Phone: +86 15151877330
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.