Ultrasonography to assist in laparoscopic surgery for obese patients
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL)
This study tests if using ultrasound to help insert a needle for surgery can make it easier and safer for obese patients getting laparoscopic weight loss surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | All India Institute of Medical Sciences, Bhubaneswar Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Bhubaneswar, Odisha) |
| Trial ID | NCT06413264 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of using ultrasonography to guide the insertion of a Veress needle for creating pneumoperitoneum in morbidly obese patients undergoing laparoscopic bariatric surgery. Patients aged 18 to 65 with a BMI over 40 kg/m2 and significant subcutaneous fat will be included. The study compares the outcomes of ultrasonography-guided needle insertion versus the traditional blind technique. Key metrics such as time taken to achieve pneumoperitoneum and complication rates will be assessed by an independent assessor.
Who should consider this trial
Good fit: Ideal candidates are morbidly obese individuals aged 18-65 with a BMI over 40 kg/m2 and significant subcutaneous fat.
Not a fit: Patients who do not understand the study or are undergoing re-do surgeries may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the safety and efficiency of laparoscopic surgeries for morbidly obese patients.
How similar studies have performed: This approach is novel, as no similar studies have been conducted to assess the role of ultrasonography in achieving pneumoperitoneum.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Patients who don't give consent and do not understand the nature of the study * Patients undergoing a re-do surgery
Where this trial is running
Bhubaneswar, Odisha
- All India Institute of Medical Sciences — Bhubaneswar, Odisha, India (Recruiting)
Study contacts
- Principal investigator: Prof. Prakash K. Sasmal, MS, FACS — Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India
- Study coordinator: Dr Prakash K. Sasmal, MS, FACS
- Email: drpksasmal@gmail.com
- Phone: +919438884255
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.