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Recruiting NCT07119437

Low Impact Laparoscopy In Bariatric Surgery

No phase Interventional Obesity, Morbid

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: low pneumoperitoneum laparoscopy with microsurgery, standard laparoscopy.
Who it may be relevant to
Registry conditions: Obesity, Morbid. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy

Overview

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

  • Procedure low pneumoperitoneum laparoscopy with microsurgery
    Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
  • Procedure standard laparoscopy
    Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).

Primary outcome measures

  • POST OPERATIVE PAIN [Time frame: FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY]
  • Pulmonary performance [Time frame: from surgery to 24 hours post-surgery]
Secondary outcome measures (11)
  • USE OF Analgesics [Time frame: from surgery to 36 hours post-surgery]
  • operative time [Time frame: from the surgical incision to the last skin stitch]
  • Rate of conversion to standard laparoscopy [Time frame: from the beginning of surgery to the end of surgery]
  • Rate of laparotomy conversion [Time frame: from the beginning of surgery to the end of surgery]
  • Ambulation Time [Time frame: From the end of surgery up to 24 hours post-surgery]
  • The time to first flatus [Time frame: From the end of surgery up to 48 hours post-surgery]
  • Liver Function [Time frame: first and second post-operative day]
  • Post-operative hospital stay [Time frame: from the day of surgery up to 30 days]
  • Postoperative complications [Time frame: from surgery to 30 days after surgery]
  • First Operator Comfort [Time frame: during surgery]
  • Aesthetic satisfaction [Time frame: from surgery to 3-month post surgery]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Italy · 1 center
  • Policlinico Campus Bio-Medico — Rome

Identifiers

NCT: NCT07119437 · 251.24 CET2 cbm

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗