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CompletedNCT03084653Updated Mar 21, 2017

Choosing the Technique for First Abdominal Entry in Laparoscopy

An observational study in Decision-Making, sponsored by Umraniye Education and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-03-21.

Sponsored by Umraniye Education and Research Hospital · Observational

Study type
Observational
Model
Other
Time perspective
Other
Enrollment
263
Ages
18 Years to 70 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Decision-Making

Keywords

  • Trocar entery
  • Surgery, Laparoscopic
03

In context

Lead sponsor

Umraniye Education and Research Hospital is the lead sponsor of 60 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
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.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • Surgical residents will be excluded from the study
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Study design

Observational model
Other
Time perspective
Other
Enrollment
263 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherSurvey

    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).

06

What researchers measure

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.

    Time frame: through study completion, an average of 1 year

07

Study locations

1 site
  • Umraniye Education and Research Hospital
    Istanbul, Ümraniye 34000, Turkey
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03084653
Lead sponsor
Umraniye Education and Research Hospital
Responsible party
Fatih Basak (Medical Doctor, Umraniye Education and Research Hospital) — Principal investigator
First posted
Mar 21, 2017
Start date
Jan 2014
Primary completion
Jun 2015
Completion
Aug 2016
Last update
Mar 21, 2017

Study contacts

Fatih Basak
principal investigator · Umraniye Education and Research Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.

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