Choosing the Technique for First Abdominal Entry in Laparoscopy

Decision-Making Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03084653
• Other study ID #: Rationale-Trocar
• Status: Completed
• Phase: N/A
• First received: March 9, 2017
• Last updated: March 14, 2017
• Start date: January 2014
• Est. completion date: August 2016

Study information

• Verified date: March 2017
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 263
• Est. completion date: August 2016
• Est. primary completion date: June 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Surgical residents will be excluded from the study

Related Conditions & MeSH terms

• Decision-Making

Intervention

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).

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	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