NCT07119437

Low Impact Laparoscopy In Bariatric Surgery

Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (estimated)
• Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to learn if low pressure pneumoperitoneum and small incisions (low impact laparoscopy, LIL) works to reduce pain and improve pulmonary function in patients underwent to bariatric surgery. It will also learn about the safety and patients' satisfaction of the procedure. The main questions it aims to answer are: Does LIL lower post surgical pain and improve pulmonary function? Is LIL safe for obese patients? Researchers will compare LIL to standard laparoscopy performing sleeve gastrectomy in patients with obesity. Participants will: be randomised to LIL group or standard laparoscopy. After the operation the researchers will evaluate the pain and the efficiency of lung ventilation at pre-established intervals. after 3 months the patients will complete a questionnaire on aesthetic satisfaction and overall satisfaction.

Conditions

• Obesity, Morbid

Interventions

Type	Name	Description
PROCEDURE	low pneumoperitoneum laparoscopy with microsurgery	Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
PROCEDURE	standard laparoscopy	Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).

Timeline

• Start date: 2025-02-04
• Primary completion: 2026-09-04
• Completion: 2026-10-04
• First posted: 2025-08-13
• Last updated: 2025-09-16

Locations

1 site across 1 country: Italy