Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06413264

Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

Led by All India Institute of Medical Sciences, Bhubaneswar · Updated on 2024-07-30

40

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 18 and 65 years
  • Undergoing laparoscopic bariatric surgery
  • Weight greater than 100 kg
  • Subcutaneous fat thickness more than 5 cm by pre-operative ultrasonography
  • Body mass index (BMI) greater than 40 kg/m2
Not Eligible

You will not qualify if you...

  • Patients who do not give consent or do not understand the study
  • Patients undergoing repeat (re-do) surgery

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

All India Institute of Medical Sciences

Bhubaneswar, Odisha, India, 751019

Actively Recruiting

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Research Team

D

Dr Prakash K. Sasmal, MS, FACS

CONTACT

D

Dr Pradeep K. Singh, MS, FACS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients | DecenTrialz