Clinical trial

Low Impact Laparoscopy In Bariatric Surgery

Recruiting now · Not applicable · 1 countries · Registry ID NCT07119437

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity, Morbid

Full registry criteria

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

Treatments and study arms

low pneumoperitoneum laparoscopy with microsurgery

Procedure

Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).

standard laparoscopy

Procedure

Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).

Primary outcomes

POST OPERATIVE PAINFROM 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 performancefrom 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)

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Policlinico Campus Bio-Medico🇮🇹 Rome, Italy, Italy

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Chiara Isabella Miligi, General surgeon's DegreeContact

Call +393891015712