Ultrasonography Guided Pneumoperitoneum for Laparoscopic Surgery in Morbidly Obese Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorAll India Institute of Medical Sciences, Bhubaneswar

About this 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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patients who don't give consent and do not understand the nature of the study

Patients undergoing a re-do surgery

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasonography guided Veress needle insertion for creating pneumoperitoneum

    Procedure/Surgery

    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 pneumoperitoneum

    Procedure/Surgery

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

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: USG-guided Veress needle insertionExperimental treatment 1 intervention
Group B: Blind Veress needle insertionActive comparator 1 intervention

Trial outcomes

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 frame
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

1

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.

Time frame
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.
2

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.

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

Other outcomes

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