NCT07119437

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress75%
Feb 2025Oct 2026

Study Start

First participant enrolled

February 4, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

February 10, 2025

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 13, 2025

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2026

Last Updated

September 16, 2025

Status Verified

February 1, 2025

Enrollment Period

1.6 years

First QC Date

February 10, 2025

Last Update Submit

September 10, 2025

Conditions

Obesity, Morbid

Keywords

obesitylow impact laparoscopysleeve gastrectomy

Outcome Measures

Primary Outcomes (2)

  • POST OPERATIVE PAIN

    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.

    FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY

  • Pulmonary performance

    Efficiency of ventilation will be evaluated recording the values of Maximum Inspiratory Pressure (MIP), maximum expiratory pressure (MEP), Peak expiratory flow (PEF)

    from surgery to 24 hours post-surgery

Secondary Outcomes (11)

  • USE OF Analgesics

    from surgery to 36 hours post-surgery

  • operative time

    from the surgical incision to the last skin stitch

  • Rate of conversion to standard laparoscopy

    from the beginning of surgery to the end of surgery

  • Rate of laparotomy conversion

    from the beginning of surgery to the end of surgery

  • Ambulation Time

    From the end of surgery up to 24 hours post-surgery

  • +6 more secondary outcomes

Study Arms (2)

Low Pneumoperitoneum Laparoscopy with microsurgery

EXPERIMENTAL
Procedure: low pneumoperitoneum laparoscopy with microsurgery

standard laparoscopy

ACTIVE COMPARATOR
Procedure: standard laparoscopy

Interventions

low pneumoperitoneum laparoscopy with microsurgeryPROCEDURE

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

Low Pneumoperitoneum Laparoscopy with microsurgery
standard laparoscopyPROCEDURE

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

standard laparoscopy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Campus Bio-Medico

Rome, Italy, 00128, Italy

RECRUITING

MeSH Terms

Conditions

Obesity, MorbidObesity

Interventions

Microsurgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgical Procedures, OperativeMicromanipulationInvestigative Techniques

Central Study Contacts

Vincenzo Bruni

CONTACT

+39 3484064965v.bruni@policlinicocampus.it

Ida Francesca Gallo

CONTACT

+393926237399i.gallo@policlinicocampus.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 10, 2025

First Posted

August 13, 2025

Study Start

February 4, 2025

Primary Completion (Estimated)

September 4, 2026

Study Completion (Estimated)

October 4, 2026

Last Updated

September 16, 2025

Record last verified: 2025-02

Locations

IT(1)