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

Role of Fascial closure in the Development of Trocar Site Hernia after Bariatric Surgery: A Randomized Control Study

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20220225005
Enrollment
224
Registered
2022-02-25
Start date
2022-04-01
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Trocar site hernia Trocar site hernia Fascial closure Bariatric surgery

Interventions

In the fascial-closure group, VersaOne Fascial Closure System will be used to close the 15-mm and 12-mm ports in patients undergoing laparoscopic sleeve gastrectomy. The 5-mm port site defects will no
Experimental Procedure/Surgery,No Intervention Procedure/Surgery
The fascial closure group ,The non-fascial closure group

Sponsors

Faculty of Medicine, Prince of Songkla University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Thailand

Contacts

Public ContactKamthorn Yolsuriyanwong

Faculty of Medicine, Prince of Songkla University

kamthorn.y@psu.ac.th6674451401

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 9, 2026