Choosing the Technique for First Abdominal Entry in Laparoscopy

Completed

• Conditions: Decision-Making
• Interventions: Other: Survey

• Registration Number: NCT03084653
• Lead Sponsor: Umraniye Education and Research Hospital

Brief Summary

Several techniques for initial abdominal entry in laparoscopy have been introduced in literature. Various guidelines and recommendations are available on this subject, however, compliance to these are controversial. The purpose of this study is to evaluate the rationale and the process of decision making for first entry technique in laparoscopy.

Detailed Description

Several methods, i.e., the Veress needle, open approach using the Hasson trocar and direct trocar insertion without insufflation have been described for initial abdominal entry in laparoscopy. On the other hand, relatively new approaches, e.g., the optical or radially expanding trocars did not become common yet. Despite the advantages of laparoscopic surgery, serious complications can be encountered during the initial entry. Development of a complication, e.g., major vascular and intestinal injury, would affect the outcome of the operation and it may result in conversion to the open approach. Because of low incidence of these complications, it is impossible to show any superiority of one approach to another.

In this study, we aimed to analyze the rationale and the process of decision making of a surgeon about initial abdominal entry technique for laparoscopy.

Study Timeline

• Study Start: 2014-01
• Primary Completion: 2015-06
• Study Completion: 2016-08
• Status Verified: 2017-03
• Study First Submitted: 2017-03-09
• Study First Submitted QC: 2017-03-14
• Last Update Submitted: 2017-03-14
• Study First Posted: 2017-03-21
• Last Update Posted: 2017-03-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 263

Inclusion Criteria

• General Surgeons who approve to participate to the study will be included.

Exclusion Criteria

• Surgical residents will be excluded from the study

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey	Survey	Close-ended survey questions were formed and will be sent to general surgeons by e-mail containing the web address of the survey.

Primary Outcome Measures

Name	Time	Method
Rationale of choice in decision-making of first abdominal trocar entry method.	through study completion, an average of 1 year	The survey will be performed to participant general surgeons to evaluate rationale of choice in decision-making of first abdominal trocar entry method.

Trial Locations

Locations (1)

Umraniye Education and Research Hospital; 🇹🇷 Istanbul, Ümraniye, Turkey