Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06413264
Status:
RECRUITING
Last Update Posted:
2024-06-26
First Post:
2024-04-28
Brief Title:
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients
Sponsor:
All India Institute of Medical Sciences Bhubaneswar
Organization:
All India Institute of Medical Sciences Bhubaneswar
Study Overview
Official Title:
Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients A Single-blinded Randomized Control Study USP TRIAL
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
USP
Brief Summary:
Bariatric Surgery for morbid obesity is indicated when BMI 40 kgm2 without comorbidities or BMI 35 kgm2 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 organorgan 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 heshe 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
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 organorgan 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 heshe 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 patients 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None