Can mesh placement prevent port site hernia after sleeve gastrectomy?

Not Applicable

Completed

• Conditions: Trocar-site hernia in obese patients undergoing bariatric surgery; Surgery

• Registration Number: ISRCTN52462725
• Lead Sponsor: Hôpital Antoine-Béclère

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/35142904/ (added 13/07/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-01-02
• Study Completion: 2021-12-31
• Last Update Posted: 5 August 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 255

Inclusion Criteria

1. Consecutive patients undergoing single-port laparoscopic with prophylactic mesh placement
2. Decision for intervention after multidisciplinary discussion
3. Sleeve gastrectomy as a primary bariatric procedure
4. Body mass index > 45 kg/m²

Exclusion Criteria

1. Previous upper abdominal surgery (cholecystectomy excepted)
2. Patient under guardianship and trusteeship
3. Patient with known allergy to mesh components

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Occurrence of trocar-site hernia during the first postoperative year observed:<br>1.1. On CT scan investigating suspicion of trocar-site hernia at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure<br>1.2. On routine systematic CT scan performed at 1 year of the surgical procedure

Secondary Outcome Measures

Name	Time	Method
1. Occurrence of complications related to the prophylactic mesh during the first postoperative year:<br>1.1. Incisional site infection at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure<br>1.2. Abdominal pain requiring grade III analgesics at the time of systematic routine clinical examination at 1 month, 3 months, 6 months and 1 year after the surgical procedure