Obesity, Morbid
Conditions
Keywords
obesity, low impact laparoscopy, sleeve gastrectomy
Brief summary
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.
Interventions
PROCEDURElow pneumoperitoneum laparoscopy with microsurgery
Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
PROCEDUREstandard laparoscopy
Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
Sponsors
Fondazione Policlinico Universitario Campus Bio-Medico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| POST OPERATIVE PAIN | FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY | 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. |
| Pulmonary performance | from surgery to 24 hours post-surgery | Efficiency of ventilation will be evaluated recording the values of Maximum Inspiratory Pressure (MIP), maximum expiratory pressure (MEP), Peak expiratory flow (PEF) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| USE OF Analgesics | from surgery to 36 hours post-surgery | Comparison of analgesic use between the two groups during post-operative recovery |
| operative time | from the surgical incision to the last skin stitch | Comparison of opertive time between the two groups |
| Rate of conversion to standard laparoscopy | from the beginning of surgery to the end of surgery | 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. |
| Rate of laparotomy conversion | from the beginning of surgery to the end of surgery | Number of cases in which the surgical procedure had to be converted from laparoscopy to an open approach. |
| Ambulation Time | From the end of surgery up to 24 hours post-surgery | Comparison of mobilization time between the two groups |
| The time to first flatus | From the end of surgery up to 48 hours post-surgery | Compare the time to intestinal motility recovery between the two groups. |
| Liver Function | first and second post-operative day | 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). |
| Post-operative hospital stay | from the day of surgery up to 30 days | Post-operative hospital stay |
| Postoperative complications | from surgery to 30 days after surgery | All postoperative complications |
| First Operator Comfort | during surgery | 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. |
| Aesthetic satisfaction | from surgery to 3-month post surgery | 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. |
Countries
Italy
Contacts
CONTACTVincenzo Bruni
CONTACTIda Francesca Gallo
Outcome results
None listed