A Prospective Clinical Trial of Colostomy-replacement Combined With Bio-mesh Placement in the Prevention of SSIH
NCT ID: NCT05627284
Last Updated: 2022-11-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
58 participants
INTERVENTIONAL
2022-10-01
2025-09-30
Brief Summary
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* 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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
PREVENTION
NONE
Study Groups
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Stoma reversal with bio-mesh placement
Stoma 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.
Interventions
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Stoma 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
75 Years
ALL
No
Sponsors
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The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
OTHER
Responsible Party
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Locations
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-LCYJ-PY-33
Identifier Type: -
Identifier Source: org_study_id
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