Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients: A Single-blinded Randomized Control Study (USP TRIAL)

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
India
All India Institute of Medical Sciences
RECRUITING
Bhubaneswar
Contact Information
Primary
Dr Prakash K. Sasmal, MS, FACS
drpksasmal@gmail.com
+919438884255
Backup
Dr Pradeep K. Singh, MS, FACS
surg_pradeep@aiimsbhubaneswar.edu.in
+919438884254
Time Frame
Start Date: 2024-07-01
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 40
Treatments
Experimental: USG-guided Veress needle insertion
Ultrasonography-guided Veress needle will be inserted, and a real-time pneumoperitoneum will be created as the first step of a laparoscopic bariatric surgical procedure. The bariatric procedures include laparoscopic sleeve gastrectomy and gastric bypass procedures. The ultrasound's high-frequency (10-13Hz) linear probe will be used peri-operatively to identify the planes of the abdominal wall. Once the Veress needle is successfully inserted into the peritoneal cavity in real-time visualisation and pneumoperitoneum created, thereafter the bariatric procedures will be continued as routinely done.
Active_comparator: Blind Veress needle insertion
The Veress needle is inserted blindly, as regularly done in any other laparoscopic surgery, and the successful pneumoperitoneum is confirmed by aspiration of the needle, saline drop test and percussion on the abdomen.
Related Therapeutic Areas
Sponsors
Leads: All India Institute of Medical Sciences, Bhubaneswar

This content was sourced from clinicaltrials.gov