Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients (USP)

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

Study Overview

• Status: Recruiting
• Conditions: Pneumoperitoneum; Morbid Obesity; Bariatric Surgery Candidate
• Intervention / Treatment: Procedure: Ultrasonography guided Veress needle insertion for creating pneumoperitoneum; Procedure: Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum

Detailed Description

All patients above the age of 18 years with morbid obesity planned for Laparoscopic bariatric surgery will be considered for inclusion in the study. The patient will be explained about the study and asked to sign an informed consent form. The patient's eligibility for the study will be checked by a competent radiologist through pre-operative ultrasonography. All patients will undergo metabolic surgery by a single competent surgeon per the standard operating protocol under general anaesthesia. A single dose of prophylactic antibiotic will be administered 30 minutes before the incision, the patient will be well strapped, and the port sites will be measured and marked. In group A, Ultrasonography will be used to locate the midline precisely and for subsequent puncturing with a Veress needle to enter the peritoneal cavity and the pneumoperitoneum created under real-time vision. In group B, the veress needle is inserted blindly, as regularly done in any other laparoscopic surgery, and the successful pneumoperitoneum is confirmed by percussion on the abdomen. Time taken and the number of attempts for achieving pneumoperitoneum and complications, if any, in both groups will be recorded by an independent assessor.

Sample size calculation :

There are no similar studies done before to assess the role of Ultrasonography in achieving pneumoperitoneum. Hence, the sample size was calculated for a pilot study, as per the recommendation of Sim J and Lewis M, considering precision, proportion, and efficiency. The trial was planned through a study of a continuous variable in two independent, Blind vs. USG guided Veress needle insertions to determine if the two study groups differ in the time taken to start pneumoperitoneum successfully.

The study used for calculating sample size :

Total sample size: 20 in each arm Blinding: Single blinded where only the patient is blinded

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Prakash K. Sasmal, MS, FACS; Phone Number: +919438884255; Email: drpksasmal@gmail.com
• Study Contact Backup: Name: Dr Pradeep K. Singh, MS, FACS; Phone Number: +919438884254; Email: surg_pradeep@aiimsbhubaneswar.edu.in

Study Locations

• India
  • Odisha
    • Bhubaneswar, Odisha, India, 751019
      • Recruiting
      • All India Institute of Medical Sciences
      • Contact: Dr Prakash K. Sasmal, MS, FACS; Phone Number: +919438884255; Email: drpksasmal@gmail.com
      • Contact: Dr Pradeep K. Singh, MS, FACS; Phone Number: +919438884254; Email: surg_pradeep@aiimsbhubaneswar.edu.in
      • Sub-Investigator: Dr Tara P Tripathy, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.; Other Names: Sonosite Edge II Portable Ultrasound machine
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.	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.; Other Names: Stainless steel spring loaded reusable hollow needle of 2mm in diameter and 15-18cm long

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidences of complications out of Veress needle insertion for creating pneumoperitoneum	To compare the incidence of complications like omental emphysema, bowel injury and vascular injury.	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
Number of attempts to successful Veress needle insertion	The number of attempts of Veress needle insertion made before successful intraperitoneal placement (confirmed by either ultrasonography/saline drop/percussion) in morbidly obese patients undergoing laparoscopic bariatric procedures. A comparison of the number of attempts of Veress needle insertion to successfully place it in the peritoneal cavity by ultrasonography-guided insertion and by the blind technique will be made.	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.

Collaborators and Investigators

• Sponsor: All India Institute of Medical Sciences, Bhubaneswar
• Investigators: Principal Investigator: Prof. Prakash K. Sasmal, MS, FACS, Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2024
• Primary Completion (Estimated): May 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 28, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 14, 2024

Study Record Updates

• Last Update Posted (Actual): July 30, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: bariatric surgery; pneumoperitoneum; metabolic surgery; Veress needle; morbidly obese; closed technique; ultrasonography-guided; access-related injury
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pneumoperitoneum; Obesity, Morbid
• Other Study ID Numbers: T/IM-NF/Gen.Surg/23/118

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The study outcome will be shared after the end of the trial. An interim study outcome will be shared after half of the study subjects are recruited.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No