PneumoperitoneumUSPNCT06413264
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients
A study testing Ultrasonography guided Veress needle insertion for creating pneumoperitoneum and Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum in people with Pneumoperitoneum and Morbid Obesity, run by All India Institute of Medical Sciences, Bhubaneswar at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pneumoperitoneum, Morbid Obesity, Bariatric Surgery Candidate
- What is being tested?
- Ultrasonography guided Veress needle insertion for creating pneumoperitoneum and Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIndia
- Study dates
- 1 Jul 2024to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 cannot join
- Patients who don't give consent and do not understand the nature of the study
- Patients undergoing a re-do surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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 :
- To quantify the thickness of subcutaneous fat
- To visualise the linea alba and guide the veress needle safely into the peritoneal cavity
- Real-time visualisation of the pneumoperitoneum created
- Avoid complications like omental emphysema, bowel or vascular injury
Read the 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
- Being tested
- Ultrasonography guided Veress needle insertion for creating pneumoperitoneum, Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum
- Keywords
- pneumoperitoneum, closed technique, Veress needle, ultrasonography-guided, morbidly obese, bariatric surgery, metabolic surgery, access-related injury
- Medical subject headings
- Pneumoperitoneum, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonography guided Veress needle insertion for creating pneumoperitoneumProcedure or surgery
Also called Sonosite Edge II Portable Ultrasound machine
A real-time visualisation of the path of the Veress needle entry by the use of high frequency (13-6 MHz) probe ultrasonography.
Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneumProcedure or surgery
Also called Stainless steel spring loaded reusable hollow needle of 2mm in diameter and 15-18cm long
The Veress needle is inserted blindly and guided by the resistance of tissues and the click sounds of layers of abdominal wall.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Veress needle will be inserted blindly as a closed technique for creating pneumoperitoneum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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
To compare the incidence of complications like omental emphysema, bowel injury and vascular injury.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2024
- Study start1 Jul 2024
- Primary completion30 Sep 2026
- Study completion30 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoperitoneumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single blinded randomised controlled study where only the patient is blinded
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- All India Institute of Medical Sciences, Bhubaneswar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Prakash Kumar Sasmal, All India Institute of Medical Sciences, Bhubaneswar
- Investigators
- Prof. Prakash K. Sasmal, MS, FACS, Principal investigator, Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06413264
- Sponsor's protocol ID
- T/IM-NF/Gen.Surg/23/118
- Acronym
- USP
- Status last verified
- Oct 2026
- First submitted
- 28 Apr 2024
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.