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

NCT ID: NCT03015935

Last Updated: 2017-01-16

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2018-05-31

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.

Detailed Description

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.

These methods include the standard technique of insufflation after insertion of the Veress needle, the open (Hasson technique), the direct trocar insertion and optical trocar insertion. Furthermore, it is more difficult to perform in the obese patient, especially if the first trocar is not umbilical, like obesity surgery. This is because obese patients have a very thick abdominal wall (particularly in women) as well as a thick peritoneum.

Very different complications, some even potentially fatal, i.e., injury to viscera or to major intra-abdominal and abdominal wall vessels, have been reported in surgical literature. Complications of first entry develop in up to 1-2% of patients and more than half of all are fatal complications. Major vascular and abdominal organ injury rates of 0.03-0.1% and 0.08-0.14%, respectively, have been reported. Surprisingly, there has been little change in entry techniques since the dawn of laparoscopic surgery. Some risk factors are defined for prediction of complications, such as obesity. Laparoscopic obesity surgery has become very attractive and gaining popularity, recently, and however it possess many complications and challenges such as (it starts with) entry to the abdomen.

Conditions

Obesity, Morbid

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Optical

visual-assisted entry

visual-assisted entry

Intervention Type: PROCEDURE

First trocar entry will be performed with visual-assisted trocar

Veress

Veress entry

Veress entry

Intervention Type: PROCEDURE

First trocar entry will be performed with Veress

Interventions

visual-assisted entry

First trocar entry will be performed with visual-assisted trocar

Intervention Type: PROCEDURE

Veress entry

First trocar entry will be performed with Veress

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Patients with body mass index of >40

Exclusion Criteria

• Patients who have skin disease at operation area

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Umraniye Education and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Fatih Basak

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fatih Basak

Role: STUDY_CHAIR

Umraniye Education and Research Hospital

Locations

Umraniye Education and Research Hospital

Istanbul, Ümraniye, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Fatih Basak, MD

Role: CONTACT

fatihbasak@gmail.com

5055034571

Facility Contacts

Fatih Basak

Role: primary

5055034571

Other Identifiers

First_Trocar_Entery

Identifier Type: -

Identifier Source: org_study_id