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NCT Number: NCT07119437

Low Impact Laparoscopy In Bariatric Surgery

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.

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Key information

Conditions

Obesity, Morbid Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Policlinico Campus Bio-Medico

Rome, Italy, 00128

Location status: Recruiting

Location contact

Chiara Isabella Miligi, General surgeon's Degree

CONTACT

+393891015712

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

  1. POST OPERATIVE PAIN

    Time frame: 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.

  2. Pulmonary performance

    Time frame: 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 outcomes

  1. USE OF Analgesics

    Time frame: from surgery to 36 hours post-surgery

    Comparison of analgesic use between the two groups during post-operative recovery

  2. operative time

    Time frame: from the surgical incision to the last skin stitch

    Comparison of opertive time between the two groups

  3. Rate of conversion to standard laparoscopy

    Time frame: 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.

  4. Rate of laparotomy conversion

    Time frame: 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.

  5. Ambulation Time

    Time frame: From the end of surgery up to 24 hours post-surgery

    Comparison of mobilization time between the two groups

  6. The time to first flatus

    Time frame: From the end of surgery up to 48 hours post-surgery

    Compare the time to intestinal motility recovery between the two groups.

  7. Liver Function

    Time frame: 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).

  8. Post-operative hospital stay

    Time frame: from the day of surgery up to 30 days

    Post-operative hospital stay

  9. Postoperative complications

    Time frame: from surgery to 30 days after surgery

    All postoperative complications

  10. First Operator Comfort

    Time frame: 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.

  11. Aesthetic satisfaction

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ida Francesca Gallo

CONTACT

[email protected]

+393926237399

Vincenzo Bruni

CONTACT

[email protected]

+39 3484064965

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Campus Bio-Medico

Other

Registry information

Official study title

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

Acronym: LILYBET

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 13, 2025
Registry last updated
Jun 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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