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NCT07119437Recruiting

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

Source: ClinicalTrials.gov · Last updated 18 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
128 (estimated)
First submitted
10 Feb 2025
Start date
4 Feb 2025
Primary completion date
4 Sept 2026
Lead sponsor
Fondazione Policlinico Universitario Campus Bio-Medico
Diseases
Obesity
NCT number
NCT07119437

What you commit to

  • Study type: Interventional
  • Planned participants: 128
  • From 4 Feb 2025 to the primary completion date, 4 Sept 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico Campus Bio-Medico
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.