Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

NCT ID: NCT06207357

Last Updated: 2024-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

403 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2023-12-15

Brief Summary

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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

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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

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Obesity, Morbid Bariatric Surgery Candidate Surgery-Complications

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Foggia

OTHER

Sponsor Role lead

Responsible Party

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Giovanna Pavone

Medical doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Giovanna Pavone

Foggia, , Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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9

Identifier Type: -

Identifier Source: org_study_id

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