Low-impact laparoscopy for sleeve gastrectomy in adults with obesity
Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Campus Bio-Medico Academic / other |
| Locations | 1 site (Rome, Italy) |
| Trial ID | NCT07119437 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Rome, Italy
- Policlinico Campus Bio-Medico — Rome, Italy, Italy (Recruiting)
Study contacts
- Study coordinator: Vincenzo Bruni
- Email: v.bruni@policlinicocampus.it
- Phone: +39 3484064965
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.