UnknownNot Applicable

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

China58 participantsStarted 2022-10-01

Plain-language 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.

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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).

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

stoma site incisional hernia

Timeframe: one-year after surgery

Trial details

NCT IDNCT05627284

SponsorThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

Contact for this trial

Yonghuan Mao, Dr

+86 15151877330 maoyonghuan@163.com

View on ClinicalTrials.gov More Stoma Site Incisional Hernia trials