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Low Impact Laparoscopy In Bariatric Surgery

NCT07119437 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 128

Last updated 2025-09-16

No results posted yet for this study

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

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).

Sponsors & Collaborators

  • Fondazione Policlinico Universitario Campus Bio-Medico

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-02-04
Primary Completion
2026-09-04
Completion
2026-10-04

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07119437 on ClinicalTrials.gov