Low-impact laparoscopy for sleeve gastrectomy in adults with obesity
Official title: Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy
Run by Fondazione Policlinico Universitario Campus Bio-Medico · NCT07119437 · Data updated 2026-11-12
This will see if low-pressure, small-incision laparoscopy reduces post-surgery pain and improves breathing after sleeve gastrectomy in adults with obesity.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 128 (estimated) |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Locations | 1 site (Rome, Italy) |
| Status | Recruiting |
| Started | February 4, 2025 |
| Main results expected | September 4, 2026 |
| Study ends | October 4, 2026 |
| Registry record updated | June 18, 2026 |
| Trial ID | NCT07119437 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18–65 with BMI between 35 and 45 kg/m2 who are candidates for sleeve gastrectomy and do not have chronic pain, neurologic/psychiatric disorders, or prior upper‑abdominal open surgery.
✕Probably not a fit
People outside the age or BMI ranges, those with chronic pain syndromes, neurologic or psychiatric disorders, or prior upper‑abdominal laparotomy may not benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with BMI 35–45 scheduled for sleeve gastrectomy will be randomly assigned to low-pressure, small-incision (low-impact) laparoscopy or standard laparoscopy. Pain scores and measures of lung ventilation will be recorded at pre-specified intervals after the operation, and safety outcomes will be monitored. Patients will complete a questionnaire on aesthetic and overall satisfaction three months after surgery. The trial is run at Policlinico Campus Bio‑Medico in Rome, Italy.
Why it matters
Potential benefit: If successful, this approach could reduce post-operative pain, improve pulmonary function after surgery, and increase patient satisfaction with smaller incisions.
How similar studies have gone: Similar low-pressure and mini‑port laparoscopy techniques have shown modest pain reductions in non‑bariatric populations, but randomized data in obese patients undergoing sleeve gastrectomy are limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Policlinico Campus Bio-Medico
Rome, Italy, Italy Recruiting
Study contacts
- Study coordinator: Vincenzo Bruni
- Email: v.bruni@policlinicocampus.it
- Phone: +39 3484064965
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.