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

Obesity, Morbid Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03015935
• Other study ID #: First_Trocar_Entery
• Status: Recruiting
• Phase: N/A
• First received: January 3, 2017
• Last updated: January 13, 2017
• Start date: January 2010
• Est. completion date: May 2018

Study information

• Verified date: January 2017
• Source: Umraniye Education and Research Hospital
• Contact: Fatih Basak, MD
• Phone: 5055034571
• Email: fatihbasak[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Patients with body mass index of >40

Exclusion Criteria:

• Patients who have skin disease at operation area

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid

Intervention

Procedure:
• visual-assisted entry
First trocar entry will be performed with visual-assisted trocar
• Veress entry
First trocar entry will be performed with Veress

Locations

Country	Name	City	State
Turkey	Umraniye Education and Research Hospital	Istanbul	Ümraniye

Sponsors (1)

Lead Sponsor	Collaborator
Umraniye Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Entry time		intraoperative