Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients
NCT06413264 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2024-07-30
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
Conditions
- Pneumoperitoneum
- Morbid Obesity
- Bariatric Surgery Candidate
Interventions
- 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.
Sponsors & Collaborators
-
All India Institute of Medical Sciences, Bhubaneswar
lead OTHER
Principal Investigators
-
Prof. Prakash K. Sasmal, MS, FACS · Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-07-01
- Primary Completion
- 2026-05-30
- Completion
- 2026-06-30
Countries
- India
Study Locations
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