RECRUITINGINTERVENTIONAL

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

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).

Locations (1)

Policlinico Campus Bio-Medico

Rome, Italy, Italy