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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Policlinico Campus Bio-Medico
RECRUITING
Rome
Contact Information
Primary
Vincenzo Bruni
v.bruni@policlinicocampus.it
+39 3484064965
Backup
Ida Francesca Gallo
i.gallo@policlinicocampus.it
+393926237399
Time Frame
Start Date: 2025-02-04
Estimated Completion Date: 2026-10-04
Participants
Target number of participants: 128
Treatments
Experimental: Low Pneumoperitoneum Laparoscopy with microsurgery
Active_comparator: standard laparoscopy
Related Therapeutic Areas
Sponsors
Leads: Fondazione Policlinico Universitario Campus Bio-Medico

This content was sourced from clinicaltrials.gov