Low Impact Laparoscopy In Bariatric Surgery

Recruiting now · Not applicable

Conditions studied: Obesity, Morbid

In brief

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.

Key facts

Study ID

NCT07119437

Run by

Fondazione Policlinico Universitario Campus Bio-Medico

People needed

128

Starts

2025-02-04

Expected to finish

2026-10-04

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age between 18 years-old and 65 years-old
• BMI (Body Mass Index) >35 Kg/m2 and < 45 Kg/m2;
• Patients candidate to sleeve gastrectomy

You may not qualify if…

• Patients with neurological and/or psychiatric disorders
• Patients with Chronic Pain Syndrome
• Patients with a history of surgical procedures using a laparotomic approach in the upper abdominal quadrants

Where it is running

• Policlinico Campus Bio-Medico — Rome, Italy, Italy (enrolling)

Full record on ClinicalTrials.gov

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