Low Impact Laparoscopy In Bariatric Surgery
ConditionObesity, Morbid
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorFondazione Policlinico Universitario Campus Bio-Medico
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- low pneumoperitoneum laparoscopy with microsurgery
- standard laparoscopy
Treatment groups
128 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov