Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

Completed

• Conditions: Surgery-Complications; Bariatric Surgery Candidate; Obesity, Morbid

• Registration Number: NCT06207357
• Lead Sponsor: University of Foggia

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2017-03-01
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-15
• Study First Submitted: 2023-12-15
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-04
• Last Update Submitted: 2024-01-04
• Study First Posted: 2024-01-17
• Last Update Posted: 2024-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 403

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
complication rate using optical trocar to create the pneumopritoneum in laparoscopic surgery	5 years	in literature we observe a low complication rate which include bowel and vessel injuries
optical trocar to induce the pneumoperitoneum	5 years	the use of optical trocar to facilitate the creation of the pneumoperitoneum in obese patients underwent bariatric surgery

Trial Locations

Locations (1)

Giovanna Pavone; 🇮🇹 Foggia, Italy