Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery

NCT03015935 | Unknown DMC

• 1 other identifier: First_Trocar_Entery
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic surgery has become very popular and standard in many indications after advancements of technique. Various methods have been used in first entry to the abdomen. Safety, wound size, to be not time-consuming, low cost, learning curve and efficacy are important. Several techniques, instruments, and approaches to minimize the risk of injury (the bowel, bladder, major abdominal vessels, and an anterior abdominal wall vessel) have been introduced. There is no consensus yet on an optimal method has yet emerged. The investigators aimed to evaluate efficacy of entry methods that ensures safe insertion of the first trocar at any site of the abdomen. To evaluate the efficacy of entry technique, the investigators used cohort of patients who will be planned to laparoscopic obesity surgery. Two methods are commonly used in surgical literature and in our center. The investigators have been used visible optical-entry technique in some patients for first entry and Veress technique in some other patients. For this purpose, the investigators designed an observational study.

Conditions

Obesity, Morbid

Keywords

Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Entry time

  intraoperative

Study Arms (2)

Optical

visual-assisted entry

Procedure: visual-assisted entry

Veress

Veress entry

Procedure: Veress entry

Interventions

visual-assisted entry PROCEDURE

First trocar entry will be performed with visual-assisted trocar

Optical

Veress entry PROCEDURE

First trocar entry will be performed with Veress

Veress

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for laparoscopic obesity surgery

You may qualify if:

• Patients with body mass index of \>40

You may not qualify if:

• Patients who have skin disease at operation area

Sponsors & Collaborators

• Umraniye Education and Research Hospital: lead

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatih Basak

  Umraniye Education and Research Hospital

  STUDY CHAIR

Central Study Contacts

Fatih Basak, MD

CONTACT

5055034571; fatihbasak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: January 3, 2017
• First Posted: January 10, 2017
• Study Start: January 1, 2010
• Primary Completion: January 1, 2018
• Study Completion: May 1, 2018
• Last Updated: January 16, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)