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NCT05627284
A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
Conditions: Stoma Site Incisional Hernia
Sex: All
Ages: 18 Years – 75 Years
Phase: NA
Enrollment: 58
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Location: China
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.
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 surgeryPreoperative 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).
Source: ClinicalTrials.gov (NCT05627284). StuddyBuddy aggregates publicly available trial information.