## Protocol Section
### Identification Module
**NCT ID:** NCT06413264

**Acronym:** USP

**Brief Title:** Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

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

#### Organization Study ID Info
**ID:** T/IM-NF/Gen.Surg/23/118
#### Organization
**Class:** OTHER
**Full Name:** All India Institute of Medical Sciences, Bhubaneswar
### Status Module
#### Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-14

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-05-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-14
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-28
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** All India Institute of Medical Sciences, Bhubaneswar

#### Responsible Party

**Investigator Affiliation:** All India Institute of Medical Sciences, Bhubaneswar

**Investigator Full Name:** Dr. Prakash Kumar Sasmal

**Investigator Title:** Professor of General Surgery

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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. 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

**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

### Conditions Module

**Conditions:**

- Pneumoperitoneum

- Morbid Obesity

- Bariatric Surgery Candidate

**Keywords:**

- pneumoperitoneum

- closed technique

- Veress needle

- ultrasonography-guided

- morbidly obese

- bariatric surgery

- metabolic surgery

- access-related injury

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

**Intervention Model Description:** Single blinded randomised controlled study where only the patient is blinded

##### Masking Info

**Masking:** SINGLE

**Masking Description:** Only patients will be blinded about the allocations.

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 40

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Procedure: Ultrasonography guided Veress needle insertion for creating pneumoperitoneum

**Label:** USG-guided Veress needle insertion

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

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

**Label:** Blind Veress needle insertion

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- USG-guided Veress needle insertion

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

**Name:** Ultrasonography guided Veress needle insertion for creating pneumoperitoneum

**Other Names:**

- Sonosite Edge II Portable Ultrasound machine

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Blind Veress needle insertion

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

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

**Other Names:**

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

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Time taken to successfully insert the Veress needle into the peritoneal cavity in both the arms.

**Time Frame:** Time taken till the Veress needle tip enters the peritoneal cavity

#### Secondary Outcomes

**Description:** 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.

**Measure:** Number of attempts of Veress needle insertion

**Time Frame:** Veress needle tip enters the peritoneal cavity (Maximum 3 attempts)

**Description:** To compare the incidence of complications like omental emphysema, bowel injury and vascular injury.

**Measure:** Incidences of complications out of Veress needle insertion for creating pneumoperitoneum

**Time Frame:** 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

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** drpksasmal@gmail.com

**Name:** Dr Prakash K. Sasmal, MS, FACS

**Phone:** +919438884255

**Role:** CONTACT

**Contact 2:**

**Email:** surg_pradeep@aiimsbhubaneswar.edu.in

**Name:** Dr Pradeep K. Singh, MS, FACS

**Phone:** +919438884254

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bhubaneswar

**Country:** India

**Facility:** All India Institute of Medical Sciences

**State:** Odisha

**Zip:** 751019

#### Overall Officials

**Official 1:**

**Affiliation:** Professor of General Surgery, All India Institute of Medical Sciences, Bhubaneswar, India

**Name:** Prof. Prakash K. Sasmal, MS, FACS

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**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.

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009765

- Term: Obesity

- ID: D000050177

- Term: Overweight

- ID: D000044343

- Term: Overnutrition

- ID: D000009748

- Term: Nutrition Disorders

- ID: D000001835

- Term: Body Weight

- ID: D000010532

- Term: Peritoneal Diseases

- ID: D000004066

- Term: Digestive System Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

- Abbrev: BC06

- Name: Digestive System Diseases

### Condition Browse Module - Browse Leaves

- ID: M12701

- Name: Obesity

- Relevance: LOW

- As Found: Unknown

- ID: M12702

- Name: Obesity, Morbid

- Relevance: HIGH

- As Found: Morbid Obesity

- ID: M13917

- Name: Pneumoperitoneum

- Relevance: HIGH

- As Found: Pneumoperitoneum

- ID: M26186

- Name: Overweight

- Relevance: LOW

- As Found: Unknown

- ID: M25307

- Name: Overnutrition

- Relevance: LOW

- As Found: Unknown

- ID: M12684

- Name: Nutrition Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

- ID: M13441

- Name: Peritoneal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000011027

- Term: Pneumoperitoneum

- ID: D000009767

- Term: Obesity, Morbid

### Misc Info Module

- Version Holder: 2024-05-31
