Low Impact Laparoscopy In Bariatric Surgery (LILYBET)

Fondazione Policlinico Universitario Campus Bio-Medico

Status

Enrolling

Conditions

Obesity, Morbid

Treatments

Procedure: standard laparoscopy

Procedure: low pneumoperitoneum laparoscopy with microsurgery

Study type

Interventional

Funder types

Other

Identifiers

NCT07119437

251.24 CET2 cbm

Details and patient eligibility

About

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.

Enrollment

128 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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