Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT07119437

Low Impact Laparoscopy In Bariatric Surgery

Led by Fondazione Policlinico Universitario Campus Bio-Medico · Updated on 2025-09-16

128

Participants Needed

1

Research Sites

86 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

Low Impact Laparoscopy In Bariatric Surgery

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 years-old and 65 years-old
  • Body Mass Index (BMI) greater than 35 Kg/m2 and less than 45 Kg/m2
  • Patients who are candidates for sleeve gastrectomy surgery
Not Eligible

You will not qualify if you...

  • Patients with neurological or psychiatric disorders
  • Patients with chronic pain syndrome
  • Patients with a history of open surgery in the upper abdominal area

AI-Screening

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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Policlinico Campus Bio-Medico

Rome, Italy, Italy, 00128

Actively Recruiting

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Research Team

V

Vincenzo Bruni

CONTACT

I

Ida Francesca Gallo

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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