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Low Impact Laparoscopy In Bariatric Surgery

RecruitingNAAges 18 Years - 65 YearsAllFondazione Policlinico Universitario Campus Bio-M…
NCT07119437 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • low pneumoperitoneum laparoscopy with microsurgery
  • standard laparoscopy
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Where

1 site
Policlinico Campus Bio-Medico
Rome, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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