NCT03084653

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
263

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
Last Updated

March 21, 2017

Status Verified

March 1, 2017

Enrollment Period

1.4 years

First QC Date

March 9, 2017

Last Update Submit

March 14, 2017

Conditions

Keywords

Trocar enterySurgery, Laparoscopic

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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

Interventions

SurveyOTHER

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).

Survey

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Surgical residents will be excluded from the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Umraniye Education and Research Hospital

Istanbul, Ümraniye, 34000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Fatih Basak

    Umraniye Education and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

January 1, 2014

Primary Completion

June 1, 2015

Study Completion

August 1, 2016

Last Updated

March 21, 2017

Record last verified: 2017-03

Locations