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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
128
Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
Policlinico Campus Bio-Medico
Rome, Italy, Italy
RECRUITINGPOST 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- SURGERY
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-surgery
USE OF Analgesics
Comparison of analgesic use between the two groups during post-operative recovery
Time frame: from surgery to 36 hours post-surgery
operative time
Comparison of opertive time between the two groups
Time frame: from the surgical incision to the last skin stitch
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 surgery
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 surgery
Ambulation Time
Comparison of mobilization time between the two groups
Time frame: From the end of surgery up to 24 hours post-surgery
The time to first flatus
Compare the time to intestinal motility recovery between the two groups.
Time frame: From the end of surgery up to 48 hours post-surgery
Liver Function
Comparison between the two groups of liver function tests that include alanine transaminase (ALT, Normal values 0-55 U/L) , aspartate transaminase (AST, normal values 5-34 U/L), alkaline phosphatase (ALP normal values 53-141 U/L) and gamma-glutamyl transferase (GGT, normal values 8-33 U/L).
Time frame: first and second post-operative day
Post-operative hospital stay
Post-operative hospital stay
Time frame: from the day of surgery up to 30 days
Postoperative complications
All postoperative complications
Time frame: from surgery to 30 days after surgery
First Operator Comfort
Evaluate the comfort of the operating surgeon related to the adequate exposure of the surgical field during the procedure using a 5-point surgical rating scale for laparoscopic surgical workspace. The scale ranges from 1 to 5, where 1 corresponds to the worst possible outcome, while 5 represents the best possible outcome.
Time frame: during surgery
Aesthetic satisfaction
Evaluate the degree of aesthetic and overall satisfaction of patients by administering to them, 3 months after the intervention, the Patient Scar Assessment Scale (PSAS), a validated tool for scar assessment, and the Ultimate Question (UQ), related to overall satisfaction. These tests are administered together and the patient, who responds to 8 different items, assigning a score from 1 to 10. The maximum test score is 80, indicating the highest satisfaction, while the minimum score is 8, corresponding to the worst possible outcome.
Time frame: from surgery to 3-month post surgery
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