Midline incisional hernia prophylaxis using synthetic mesh in emergency or urgency gastrointestinal tract surgery: A multicenter randomized clinical trial

Phase 3

• Conditions: emergency/urgency operated gastrointestinal conditions; prophylactic mesh; retrorectus mesh; incisional hernia

• Registration Number: TCTR20200924002
• Lead Sponsor: Vajira Hospital, Navamindradhiraj University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-24
• Study Completion: 2022-10-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 470

Inclusion Criteria

1. Adults age ≥ 18 years
2. Surgery within 24 hours after admission or consultation with suspected GI pathology
3. Receipt of midline abdominal incision with an incision length of at least 1/4 of the distance from the xiphoid process to the pubic symphysis
4. Have an American Society of Anesthesiologist (ASA) physical status class 1-4

Exclusion Criteria

1. Any of following conditions:
1.1. Septic shock (hemodynamic instability)
1.2. Metastatic cancer (stage IV) at before or during operation
1.3. Dirty surgical wound with severe contamination from fecal material and frank pus (surgical wound class IV)
1.4. Massive devitalized bowel ischemia
2. potential second-look operation or planned revisionary surgery via a midline incision
3. secondary fascial closure
4. existence of midline incisional hernia and/or history of midline incisional hernia repair
5. pregnancy or plan for pregnancy after surgery
6. connective tissue disorders
7. current or planned immunosuppressive use
8. allergy to polypropylene

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
incisional hernia at 3, 6, 12, 18, and 24 months detected by clinical examination and/or radiologic study