Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
128 participants
INTERVENTIONAL
2025-02-04
2026-10-04
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Bariatric Endoscopy for Treatment of Obesity
NCT04854317
REduced Pain After Bariatric Surgery - Sleeve Gastrectomy
NCT06383234
A Study to Compare Two Techniques for Pain Control After Bariatric Surgery
NCT04427059
REduced Pain After Bariatric Surgery - Gastric Bypass
NCT06614257
Proteomics in Morbid Obesity After Bariatric Surgery
NCT01151917
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Low Pneumoperitoneum Laparoscopy with microsurgery
low pneumoperitoneum laparoscopy with microsurgery
Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
standard laparoscopy
standard laparoscopy
Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
low pneumoperitoneum laparoscopy with microsurgery
Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
standard laparoscopy
Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* BMI (Body Mass Index) \>35 Kg/m2 and \< 45 Kg/m2;
* Patients candidate to sleeve gastrectomy
Exclusion Criteria
* Patients with Chronic Pain Syndrome
* Patients with a history of surgical procedures using a laparotomic approach in the upper abdominal quadrants
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fondazione Policlinico Universitario Campus Bio-Medico
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Policlinico Campus Bio-Medico
Rome, Italy, Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Chiara Isabella Miligi, General surgeon's Degree
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
251.24 CET2 cbm
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.