Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

NCT06413264 | Recruiting DMC

• 1 other identifier: T/IM-NF/Gen.Surg/23/118
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. 1.To quantify the thickness of subcutaneous fat
2. 2.To visualise the linea alba and guide the veress needle safely into the peritoneal cavity
3. 3.Real-time visualisation of the pneumoperitoneum created
4. 4.Avoid complications like omental emphysema, bowel or vascular injury

Conditions

Pneumoperitoneum; Morbid Obesity; Bariatric Surgery Candidate

Keywords

pneumoperitoneum; closed technique; Veress needle; ultrasonography-guided; morbidly obese; bariatric surgery; metabolic surgery; access-related injury

Outcome Measures

Primary Outcomes (1)

• Time taken to successfully insert the Veress needle (supra umbilical) into the peritoneal cavity in both arms.

  The time in seconds between the first attempt to insert the Veress needle into the peritoneal cavity and the onset of successful pneumoperitoneum (confirmed by either ultrasonography/saline drop/percussion) in morbidly obese patients undergoing laparoscopic bariatric procedures. A comparison of the time taken to successfully place the Veress needle in the peritoneal cavity by ultrasonography-guided insertion and by blind technique will be made.

  Time taken till the Veress needle tip enters the peritoneal cavity (Maximum allowed time up to 2 minutes). Beyond the time, the Veress needle to be attempted insertion at other sites, including the Palmer's point.

Secondary Outcomes (2)

• Number of attempts to successful Veress needle insertion

  Veress needle tip enters the peritoneal cavity (Upto maximum 3 attempts within 2 minutes). Beyond the number of attempts or time, the Veress needle to be attempted insertion at other sites, including the Palmer's point.

• Incidences of complications out of Veress needle insertion for creating pneumoperitoneum

  At the beginning of the laparoscopic surgical procedure, during the diagnostic laparoscopy, the complications (omental emphysema, bowel /vascular injury), if any inadvertently done will be recorded

Study Arms (2)

USG-guided Veress needle insertion

EXPERIMENTAL

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.

Procedure: Ultrasonography guided Veress needle insertion for creating pneumoperitoneum

Blind Veress needle insertion

ACTIVE COMPARATOR

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.

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

Interventions

Ultrasonography guided Veress needle insertion for creating pneumoperitoneum PROCEDURE

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

Also known as: Sonosite Edge II Portable Ultrasound machine

USG-guided Veress needle insertion

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

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

Also known as: Stainless steel spring loaded reusable hollow needle of 2mm in diameter and 15-18cm long

Blind Veress needle insertion

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients who don't give consent and do not understand the nature of the study
• Patients undergoing a re-do surgery

Sponsors & Collaborators

• All India Institute of Medical Sciences, Bhubaneswar: lead

Study Sites (1)

All India Institute of Medical Sciences

Bhubaneswar, Odisha, 751019, India

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum; Obesity, Morbid

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases; Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prof. Prakash K. Sasmal, MS, FACS

  Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Prakash K. Sasmal, MS, FACS

CONTACT

+919438884255; drpksasmal@gmail.com

Dr Pradeep K. Singh, MS, FACS

CONTACT

+919438884254; surg_pradeep@aiimsbhubaneswar.edu.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only patients will be blinded about the allocations.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of General Surgery

Model Details: Single blinded randomised controlled study where only the patient is blinded

Study Record Dates

• First Submitted: April 28, 2024
• First Posted: May 14, 2024
• Study Start: July 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: July 30, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)