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

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ClinicalTrials.gov Identifier: NCT03015935
Recruitment Status : Unknown
Verified January 2017 by Fatih Basak, Umraniye Education and Research Hospital.
Recruitment status was:  Recruiting
First Posted : January 10, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Fatih Basak, Umraniye Education and Research Hospital

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.


Condition or disease Intervention/treatment
Obesity, Morbid 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.


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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safe and Easy Access Technique for the First Trocar in Laparoscopic Obesity Surgery. A Prospective Controlled-cohort Study
Study Start Date : January 2010
Estimated Primary Completion Date : January 2018
Estimated Study Completion Date : May 2018

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




Primary Outcome Measures :
  1. Entry time [ Time Frame: intraoperative ]


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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients who are eligible for laparoscopic obesity surgery
Criteria

Inclusion Criteria:

  • Patients with body mass index of >40

Exclusion Criteria:

  • Patients who have skin disease at operation area

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015935


Contacts
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Contact: Fatih Basak, MD 5055034571 fatihbasak@gmail.com

Locations
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Turkey
Umraniye Education and Research Hospital Recruiting
Istanbul, Ümraniye, Turkey, 34000
Contact: Fatih Basak    5055034571      
Sponsors and Collaborators
Umraniye Education and Research Hospital
Investigators
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Study Chair: Fatih Basak Umraniye Education and Research Hospital

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Responsible Party: Fatih Basak, Medical Doctor, Umraniye Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03015935     History of Changes
Other Study ID Numbers: First_Trocar_Entery
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Fatih Basak, Umraniye Education and Research Hospital:
Obesity, Morbid
Additional relevant MeSH terms:
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Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms