NCT06413264

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)
All India Institute of Medical Sciences, Bhubaneswar·ClinicalTrials.gov·procedureNot yet recruiting
View on ClinicalTrials.gov
Study focus
Drug/Device/Intervention
Ultrasonography guided Veress needle insertion for creating pneumoperitoneum
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
All India Institute of Medical Sciences, Bhubaneswar
Location
Bhubaneswar, India
Timeline & enrollment
Phase
N/A
Start date
Jun 01, 2024
End date
Jun 30, 2026
Enrollment
40 participants
Primary outcome

Time taken to successfully insert the Veress needle into the peritoneal cavity in both the arms.

Summary

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

ICD-10 classifications
Postgastric surgery syndromesObesity, unspecifiedAttention to gastrostomyOther obesityObesity due to excess calories
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06413264
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06413264 through Pure Global AI's free database. This phase not specified trial is sponsored by All India Institute of Medical Sciences, Bhubaneswar and is currently Not yet recruiting. The study focuses on Pneumoperitoneum,Morbid Obesity,Bariatric Surgery Candidate. Target enrollment is 40 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.