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

Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study

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.

Study Overview

• Status: Unknown
• Conditions: Obesity, Morbid
• Intervention / Treatment: Procedure: visual-assisted entry; Procedure: Veress entry

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.

• Study Type: Observational
• Enrollment (Anticipated): 500

Contacts and Locations

• Study Contact: Name: Fatih Basak, MD; Phone Number: 5055034571; Email: fatihbasak@gmail.com

Study Locations

• Turkey
  • Ümraniye
    • Istanbul, Ümraniye, Turkey, 34000
      • Recruiting
      • Umraniye Education and Research Hospital
      • Contact: Fatih Basak; Phone Number: 5055034571

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who are eligible for laparoscopic obesity surgery

Description

Inclusion Criteria:

• Patients with body mass index of >40

Exclusion Criteria:

• Patients who have skin disease at operation area

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Optical; visual-assisted entry	Procedure: visual-assisted entry; First trocar entry will be performed with visual-assisted trocar
Veress; Veress entry	Procedure: Veress entry; First trocar entry will be performed with Veress

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Entry time	intraoperative

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Study Chair: Fatih Basak, Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Anticipated): January 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: January 3, 2017
• First Submitted That Met QC Criteria: January 6, 2017
• First Posted (Estimate): January 10, 2017

Study Record Updates

• Last Update Posted (Estimate): January 16, 2017
• Last Update Submitted That Met QC Criteria: January 13, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: Obesity, Morbid
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Obesity, Morbid
• Other Study ID Numbers: First_Trocar_Entery

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO