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RECRUITINGINTERVENTIONAL

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)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - Patients who don't give consent and do not understand the nature of the study - Patients undergoing a re-do surgery Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

PROCEDURE

Ultrasonography guided Veress needle insertion for creating pneumoperitoneum

A real-time visualisation of the path of the Veress needle entry by the use of high frequency (13-6 MHz) probe ultrasonography.

PROCEDURE

Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum

The Veress needle is inserted blindly and guided by the resistance of tissues and the click sounds of layers of abdominal wall.

Locations (1)

All India Institute of Medical Sciences
Bhubaneswar, Odisha, India