Optical Trocar to Create the Pneumoperitoneum in Bariatric Patients

NCT06207357 | Completed

• 1 other identifier: 9
• Study Type: observational
• Target: 403
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid; Bariatric Surgery Candidate; Surgery-Complications

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Interventions

optical trocar to create the pneumoperitoneum for bariatric surgery PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Body mass index (BMI) ≥35-39 kg/m2 with one obesity- associated co-morbidity or BMI≥40kg/m2, age ≥ 18 years.

You may qualify if:

• BMI\>40 kg/m2 BMI\>35 kg/m2with at least one associated major comorbidity

You may not qualify if:

• secondary obesity due to endocrine and psychological disorders

Sponsors & Collaborators

• University of Foggia: lead

Study Sites (1)

Giovanna Pavone

Foggia, 71122, Italy

Location

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: December 15, 2023
• First Posted: January 17, 2024
• Study Start: March 1, 2017
• Primary Completion: November 30, 2023
• Study Completion: December 15, 2023
• Last Updated: January 17, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)