Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06207357
• Other study ID #: 9
• Status: Completed
• Start date: March 1, 2017
• Est. completion date: December 15, 2023

Study information

• Verified date: January 2024
• Source: University of Foggia
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: December 15, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Obesity, Morbid
• Pneumoperitoneum

Intervention

Procedure:
• optical trocar to create the pneumoperitoneum for bariatric surgery
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.

Locations

Country	Name	City	State
Italy	Giovanna Pavone	Foggia

Sponsors (1)

Lead Sponsor	Collaborator
University of Foggia

Country where clinical trial is conducted

Italy, 

Outcome

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