Role of Fascial closure in the Development of Trocar Site Hernia after Bariatric Surgery

Phase 2

• Conditions: Trocar site hernia; Fascial closure; Bariatric surgery

• Registration Number: TCTR20220225005
• Lead Sponsor: Faculty of Medicine, Prince of Songkla University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-25
• Last Update Posted: 19 August 2024
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: Pending (Not yet recruiting)
• Sex: All
• Target Recruitment: 224

Inclusion Criteria

Morbid obese patients, who are undergoing laparoscopic sleeve gastrectomy at Songklanagarind Hospital, Thailand with a:
- Body mass index (BMI) equal or more than 37.5 kg/m2
- BMI equal or more than 32.5 kg/m2 with obesity-related co-morbidity

Exclusion Criteria

-Previous upper abdominal surgery
-Recent diagnosis of ventral hernia
- Patient with any cause that may increase intraabdominal pressure such as ascites, COPD or chronic cough etc.
-Contraindications for Bariatric surgery:
1. Pregnant patients.
2. Patients who are unable to comply to continuous medical follow-ups as required.
3. Patients with non-stabilized psychotic disorders, severe depression, or personality and eating disorders; specifically advised by psychiatrist/psychologist.
4. Patients with reversible endocrine disorder that can cause obesity.
5. Patients with alcohol abuse and/or drug dependencies.
6. Patients with diseases threatening their life in the short term (ASA-4).
7. Patients who are unable to care for themselves, and have no long-term family or social support to provide such care.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trocar site hernia 1, 3 and 5 years after surgery Compare the incidence of trocar site hernia of the 12-mm and 15-mm trocar site between the fascial closure group and non-fascial closure group

Secondary Outcome Measures

Name	Time	Method
Trocar site hernia 1, 3 and 5 years after surgery number and percentage,risk factors of trocar site hernia 1, 3 and 5 years after surgery regression models,post-operative pain within 72 hours after surgery Compare the Numerical rating scale (NRS) ,the complications of the fascial closure procedure intraoperative period and within 30 days after surgery number and percentage