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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
low pneumoperitoneum laparoscopy with microsurgery
Procedure/SurgeryUse of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
standard laparoscopy
Procedure/SurgeryStandard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
Treatment groups
128 Participants
are divided into 2 treatment groupsGroup A: Low Pneumoperitoneum Laparoscopy with microsurgeryExperimental treatment 1 intervention
Group B: standard laparoscopyActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
POST OPERATIVE PAIN
Post-operative pain (AS REST PAIN AND MOVIMENT PAIN) will be assessed using the Numeric Pain Rating Scale (NRS), which rates pain from 0 to 10. 0 is defined as no pain, while 10 represents the maximum pain. 0 is the best result, 10 the worst. The questionnaire will be administered in the PACU and at 6, 12, 24, and 36 hours after the end of the procedure.
Time frame
FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY2
Pulmonary performance
Efficiency of ventilation will be evaluated recording the values of Maximum Inspiratory Pressure (MIP), maximum expiratory pressure (MEP), Peak expiratory flow (PEF)
Time frame
from surgery to 24 hours post-surgerySecondary outcomes
1
USE OF Analgesics
Comparison of analgesic use between the two groups during post-operative recovery
Time frame
from surgery to 36 hours post-surgery2
operative time
Comparison of opertive time between the two groups
Time frame
from the surgical incision to the last skin stitch3
Rate of conversion to standard laparoscopy
Record the number of cases in the operative group where conversion to a standard laparoscopic approach was necessary, with pressure values \> 10 mmHg for more than 20% of the duration of the procedure. Also analyzing the results for BMI subgroups.
Time frame
from the beginning of surgery to the end of surgery4
Rate of laparotomy conversion
Number of cases in which the surgical procedure had to be converted from laparoscopy to an open approach.
Time frame
from the beginning of surgery to the end of surgerySponsors and contacts
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Source ClinicalTrials.gov