Which Trocar Access Site Should We Use in Laparoscopic Appendectomy?

March 28, 2022 updated by: Ersin Gündoğan, Inonu University
Open appendectomy has been used in the treatment of appendicitis, which is among the most common emergency pathologies worldwide, since the end of the 19th century. In the 20th century, laparoscopic appendectomy came to the fore and the frequency of use increased gradually. Despite the frequency of laparoscopic appendectomy, there is no consensus on the best way to perform each procedural step. One of these steps is the trocar entry areas. In this study, investigator's aim is to compare the trocar entry areas, which are various reports in the literature, and to find the localization with the optimal usage area. 140 patients who underwent laparoscopic appendectomy between 2021-2022 were randomized into four groups and included in the study. Demographic data, peroperative findings, complications, length of stay and post-operative VAS values of the patients were evaluated.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocasinan
      • Kayseri, Kocasinan, Turkey, 38090
        • Ersin Gundogan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients who underwent laparoscopic appendectomy

Exclusion Criteria:

patients who underwent open surgery and did not want to be involved in the study process

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
trocar entry areas:Periumblical, left lower quadrant, suprapubic
Procedure: Only different trocar sites
Only different trocar sites in literature
Active Comparator: Group 2
trocar entry areas: Periumblical, left lower quadrant, right lower quadrant
Procedure: Only different trocar sites
Only different trocar sites in literature
Active Comparator: group 3
trocar entry areas: Periumblical, right lower quadrant, suprapubic
Procedure: Only different trocar sites
Only different trocar sites in literature
Active Comparator: Group 4
trocar entry areas: Periumblical, left lower quadrant, left upper quadrant
Procedure: Only different trocar sites
Only different trocar sites in literature

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Intensity measure
Time Frame: 1 year
self reported pain intensity morning. item is scored 0-10 ( 0: no pain- 10: pain as bad as
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

December 30, 2021

Study Completion (Actual)

February 20, 2022

Study Registration Dates

First Submitted

March 14, 2022

First Submitted That Met QC Criteria

March 28, 2022

First Posted (Actual)

April 5, 2022

Study Record Updates

Last Update Posted (Actual)

April 5, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2021/267

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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