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Clinical Trials/NCT06207357
NCT06207357CompletedNot Applicable

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

University of Foggia1 site in 1 country403 target enrollmentStarted: March 1, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
403
Locations
1
Primary Endpoint
complication rate using optical trocar to create the pneumopritoneum in laparoscopic surgery

Study Overview

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

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

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
University of Foggia
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giovanna Pavone

Medical doctor

University of Foggia

Study Sites (1)

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