Clinical Trials Directory

Trials / Completed

CompletedNCT06207357

Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

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

Status
Completed
Phase
Study type
Observational
Enrollment
403 (actual)
Sponsor
University of Foggia · Academic / Other
Sex
All
Age
18 Years – 65 Years
Healthy volunteers
Accepted

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

Conditions

Interventions

TypeNameDescription
PROCEDUREoptical trocar to create the pneumoperitoneum for bariatric surgeryThe 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.

Timeline

Start date
2017-03-01
Primary completion
2023-11-30
Completion
2023-12-15
First posted
2024-01-17
Last updated
2024-01-17

Locations

1 site across 1 country: Italy

Source: ClinicalTrials.gov record NCT06207357. Inclusion in this directory is not an endorsement.