NCT06413264Completed
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL)
Source: ClinicalTrials.gov · Last updated 14 Oct 2026
Brief summary (registry, in English)
Bariatric Surgery for morbid obesity is indicated when BMI \> 40 kg/m2 without comorbidities or BMI \> 35 kg/m2 with co-morbidities. Different surgeries performed for obesity are classified as restrictive, malabsorptive, and hybrid procedures. Because laparoscopic surgery has increased the interest and growth of bariatric surgery, soaring demand for laparoscopic bariatric surgery from patients has boosted the boom in bariatric surgery worldwide. Achieving pneumoperitoneum is the initial and one of the most crucial steps in any laparoscopic surgery, giving the surgeon working space to operate on a particular organ/organ system. Usually, pneumoperitoneum is achieved either by a closed technique with a veress needle or an open technique with many variations like finger assisted or the conventional open technique. Given the excess amount of subcutaneous fat in morbidly obese patients, putting a veress needle to achieve pneumoperitoneum successfully is particularly challenging which takes a toll on the operating surgeon when he/she is trying to locate the midline one can either overshoot to cause omental emphysema or undershoot getting lost in the subcutaneous fat. It is usually done in the supra umbilical area. Sometimes, due to previous surgical scars other sites are preferred. Sonography is routinely used by radiologists with negligible radiation exposure. Anesthesiologists in the operating room have used it for many assisted procedures like central line insertion / giving nerve blocks. It can also be used in obese patients undergoing metabolic surgery to assist in creating pneumoperitoneum by a veress needle. Advantages of Intraoperative ultrasonography in this particular study : 1. To quantify the thickness of subcutaneous fat 2. To visualise the linea alba and guide the veress needle safely into the peritoneal cavity 3. Real-time visualisation of the pneumoperitoneum created 4. Avoid complications like omental emphysema, bowel or vascular injury
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 28 Apr 2024
- Start date
- 1 Jul 2024
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Diseases
- Obesity
- NCT number
- NCT06413264
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 1 Jul 2024 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing a re-do surgery
Other
- Patients who don't give consent and do not understand the nature of the study
Who the study is looking for
- All patients in the age group of 18 -65 years undergoing laparoscopic bariatric surgery with weight \>100 kg
- Subcutaneous fat thickness of more than 5 cm as determined by pre-operative ultrasonography
- BMI \> 40 kg/m2
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| All India Institute of Medical Sciences Coordinator of this site? Confirm its status | Bhubaneswar | India | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.