Obesity, MorbidLILYBETNCT07119437
Low Impact Laparoscopy In Bariatric Surgery
A study testing low pneumoperitoneum laparoscopy with microsurgery and standard laparoscopy in people with Obesity, Morbid, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- low pneumoperitoneum laparoscopy with microsurgery and standard laparoscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteItaly
- Study dates
- 4 Feb 2025to 4 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Policlinico Campus Bio-Medico
Rome, Italy, 00128
Chiara Isabella Miligi, General surgeon's Degree, +393891015712
About this study
Official title: Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy
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:
Read more
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.
- Conditions
- Obesity, Morbid
- Being tested
- low pneumoperitoneum laparoscopy with microsurgery, standard laparoscopy
- Keywords
- obesity, low impact laparoscopy, sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low pneumoperitoneum laparoscopy with microsurgeryProcedure or surgery
Use of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy).
standard laparoscopyProcedure or surgery
Standard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy).
| Study group | Role | What they receive |
|---|---|---|
| Low Pneumoperitoneum Laparoscopy with microsurgery | Experimental | Not described Receives: Procedure: low pneumoperitoneum laparoscopy with microsurgery |
| standard laparoscopy | Active comparator | Not described Receives: Procedure: standard laparoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
Measured: from surgery to 24 hours post-surgery
Secondary outcomes (11)
USE OF Analgesics
Comparison of analgesic use between the two groups during post-operative recovery
Measured: from surgery to 36 hours post-surgery
operative time
Comparison of opertive time between the two groups
Measured: from the surgical incision to the last skin stitch
Rate of conversion to standard laparoscopy
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.
Measured: from the beginning of surgery to the end of surgery
Rate of laparotomy conversion
Number of cases in which the surgical procedure had to be converted from laparoscopy to an open approach.
Measured: from the beginning of surgery to the end of surgery
Ambulation Time
Comparison of mobilization time between the two groups
Measured: From the end of surgery up to 24 hours post-surgery
The time to first flatus
Compare the time to intestinal motility recovery between the two groups.
Measured: From the end of surgery up to 48 hours post-surgery
Liver Function
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).
Measured: first and second post-operative day
Post-operative hospital stay
Post-operative hospital stay
Measured: from the day of surgery up to 30 days
Postoperative complications
All postoperative complications
Measured: from surgery to 30 days after surgery
First Operator Comfort
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.
Measured: during surgery
Aesthetic satisfaction
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.
Measured: from surgery to 3-month post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start4 Feb 2025
- Primary completion4 Sep 2026 (estimated)
- Study completion4 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-Medico
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119437
- Sponsor's protocol ID
- 251.24 CET2 cbm
- Acronym
- LILYBET
- Status last verified
- Feb 2026
- First submitted
- 10 Feb 2025
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Impact Laparoscopy In Bariatric Surgery- A Monocentric Randomised Trial Comparing Low-Pressure Pneumoperitoneum Plus Microsurgery Versus Standard Laparoscopy
- ClinicalTrials.gov ID
- NCT07119437
- Acronym / sponsor ID
- LILYBET / 251.24 CET2 cbm
- Conditions
- Obesity, Morbid
- Keywords
- obesity, low impact laparoscopy, sleeve gastrectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Campus Bio-MedicoUniversity, hospital or other
- Study start
- 4 Feb 2025 (actual)
- Primary completion
- 4 Sep 2026 (estimated)
- Study completion
- 4 Oct 2026 (estimated)
- First posted
- 13 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Pneumoperitoneum Laparoscopy with microsurgery | Experimental | Procedure: low pneumoperitoneum laparoscopy with microsurgery |
| standard laparoscopy | Active comparator | Procedure: standard laparoscopy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| low pneumoperitoneum laparoscopy with microsurgeryUse of low pressure for pneumoperitoneum (8-10 mmHg) and mini surgical access for bariatric procedure (sleeve gastrectomy). | Procedure or surgery | Low Pneumoperitoneum Laparoscopy with microsurgery |
| standard laparoscopyStandard laparoscopy (12-14 mmHg) and normal surgical access for bariatric procedures (sleeve gastrectomy). | Procedure or surgery | standard laparoscopy |
Primary outcome
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.
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)
11 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low pneumoperitoneum laparoscopy with microsurgery and standard laparoscopy in people with Obesity, Morbid, run by Fondazione Policlinico Universitario Campus Bio-Medico at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Vincenzo Bruni (+39 3484064965, v.bruni@policlinicocampus.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
POST OPERATIVE PAIN (time frame: FROM THE ENTER IN PACU TO 36 HOURS POST- SURGERY). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026.