Choosing the Technique for First Abdominal Entry in Laparoscopy

Choosing the Technique for First Abdominal Entry in Laparoscopy: A Questionnaire-based Observational Study.

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.

Study Overview

• Status: Completed
• Conditions: Decision-Making
• Intervention / Treatment: Other: Survey

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 Type: Observational
• Enrollment (Actual): 263

Contacts and Locations

Study Locations

• Turkey
  • Ümraniye
    • Istanbul, Ümraniye, Turkey, 34000
      • Umraniye Education and Research Hospital

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

Close-ended survey questions were formed and sent to general surgeons by e-mail containing the web address of the survey.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

Other: Survey; Close-ended survey will be performed to the participants. The survey consisted of 18 questions (Appendix). The first six questions (#1-6) were related with respondent's demographical and educational data and experiences of surgical and laparoscopic practices. There were five questions to determine preferred technique for first entry (#7-11), three questions for complications (#12-14), and remaining four questions for safety maneuvers (#15-18).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Umraniye Education and Research Hospital
• Investigators: Principal Investigator: Fatih Basak, Umraniye Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 9, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): March 21, 2017
• Last Update Submitted That Met QC Criteria: March 14, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Surgery, Laparoscopic; Trocar entery
• Other Study ID Numbers: Rationale-Trocar

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No