Stoma Site Incisional Hernia
Conditions
Keywords
Stoma Site Incisional Hernia, Colon cancer
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.
Interventions
PROCEDUREStoma 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.
Sponsors
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| stoma site incisional hernia | one-year after surgery | Hernia occurs on the primary stoma site |
Countries
China
Contacts
Primary ContactYonghuan Mao, Dr
Outcome results
None listed