LOW IMPACT LAPAROSCOPY IN BARIATRIC SURGERY

Not Applicable

Recruiting

• Conditions: Obesity, Morbid

• Registration Number: NCT07119437
• Lead Sponsor: Fondazione Policlinico Universitario Campus Bio-Medico

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-02
• Study Start: 2025-02-04
• Study First Submitted: 2025-02-10
• Study First Submitted QC: 2025-08-05
• Last Update Submitted: 2025-08-05
• Study First Posted: 2025-08-13
• Last Update Posted: 2025-08-13
• Primary Completion: 2026-09-04
• Study Completion: 2026-10-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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
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.
Ambulation Time	From the end of surgery up to 24 hours post-surgery	Comparison of mobilization time 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.

Trial Locations

Locations (1)

Policlinico Campus Bio-Medico; 🇮🇹 Rome, Italy