Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

Laparoscopic bariatric surgery are becoming the most used procedure to treat the obesity. To facilitate safe initial access to the abdominal cavity, we insert an optical viewing trocar at the left hypocondrium. The aim of this study is to systematically evaluate all published data existing in the literature to analyze the safety of optical trocars in patients undergoing bariatric surgery and to compare these data with our experiences.

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Key information

Conditions

Obesity, Morbid Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Surgery-Complications

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Giovanna Pavone

Foggia, 71122, Italy

About this study

In this study we analyze data existing in the literature about the use of the optical trocars in patients undergoing bariatric surgery and we compare these data with our experiences.

Establishing pneumoperitoneum is classically performed using a Veress needle or the open Hasson technique, but obesity presents its own challenges when using these techniques, including thickened abdominal wall, variable anatomical landmarks, difficult and time-consuming dissection, air leak, inadequate pneumoperitoneum, subcutaneous emphysema, and difficulty with fascial closure

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

BMI>40 kg/m2 BMI>35 kg/m2with at least one associated major comorbidity

Exclusion criteria

secondary obesity due to endocrine and psychological disorders

Treatment and study plan

optical trocar to create the pneumoperitoneum for bariatric surgery

Procedure

The technique involves the use of 4 12 mm trocars. Pneumoperitoneum is induced by a 0° optical trocar and maintained at 15 mmHg. The first trocar is usually inserted along the left mid-clavicular line approximately 2 fingers from the costal arch, another trocar along the left axillary line, a third trocar 1 cm to the right of the midline, and the fourth trocar along the right mid-clavicular line. A 10 mm, 30 ° laparoscope is used.

Primary outcomes

optical trocar to induce the pneumoperitoneum

Time frame: 5 years

the use of optical trocar to facilitate the creation of the pneumoperitoneum in obese patients underwent bariatric surgery
complication rate using optical trocar to create the pneumopritoneum in laparoscopic surgery

Time frame: 5 years

in literature we observe a low complication rate which include bowel and vessel injuries

Sponsors and collaborators

Lead sponsor

University of Foggia

Other

Registry information

Official study title

Optical Trocar to Facilitate the Pneumoperitoneum Creation in Bariatric Patients: Our Experience and Systematic Review

Important dates

Study start: 2017
Primary completion: 2023
Study completion: 2023
First posted: Jan 17, 2024
Registry last updated: Jan 17, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed