Is Routine Use of Histopathological Examination Necessary After Cholecystectomy ?

February 16, 2019 updated by: Ufuk Oguz Idiz, Sisli Hamidiye Etfal Training and Research Hospital
Cholecystectomy has been made with benign conditions usually. The aim of this study is to compare the macroscopic evaluations of the cholecystectomy specimens with it's histopathological examinations.

Study Overview

Status

Completed

Conditions

Detailed Description

Cholecystectomy is one of the most frequently performed surgery in the world and often made with benign conditions. Routinely cholecystectomy specimens sent for histopathologic examination. The histopathologic examination of the cholecystectomy specimens are benign in most of the cases and the incidental malignancy of the gallbladder is 2-2.9% in the literature. The histopathologic evaluations of the gallbladder come with additional workload for pathology and surgery departments. Also there is additional cost for the patients. Because of that the idea of selective histopathologic examination has been raised.

Study Type

Observational

Enrollment (Actual)

1000

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
      • Bursa, Turkey
        • Bursa Yuksek Ihtisas Training and Research Hospital
      • Erzincan, Turkey
        • Erzincan University
      • Istanbul, Turkey, 34371
        • Sisli Etfal Training and Research Hospital
      • Istanbul, Turkey, 34093
        • Bezmialem Vakif University
      • Istanbul, Turkey
        • Arnavutkoy State Hospital
      • Istanbul, Turkey
        • Istanbul Training and Research Hospital

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 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

1000 patients who is operated with non inflamated cholelithiasis will be included to this study.

Description

Inclusion Criteria:

  • Subject has cholelithiasis

Exclusion Criteria:

  • Subject has acute cholecystitis
  • Subject has perforated gallbladder
  • Subject has malignancy
  • Subject has polyps in the gallbladder
  • Subject has increasing wall thickness of the gallbladder
  • Subject has malignancy in the preoperative ultrasonography in the gallbladder
  • Subject has pregnancy

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Benign
Benign pathology specimens with macroscopically
Suspicious
Suspicious group includes the conditions such as increasing of the gallbladder wall thickness, having calcifications or polyps in the gallbladder.
Malign
Malign group includes the conditions such as detecting mass or irregularities in the gallbladder wall.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The comparison of macroscopic and histopathologic examination of the cholecystectomy specimen with 1000 cases
Time Frame: 15 days
The 1000 cholecystectomy specimens will be evaluated macroscopically by two experienced surgeons with a longitudinal incision to the gallbladder. The specimens will be grouped as benign, suspicious, malign according to the surgeon's decision. To confirm the surgeon's macroscopic evaluation, all of the specimens will be evaluated histopathologically. The results of macroscopic and histopathological examinations will be compared.
15 days

Collaborators and Investigators

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

Sponsor

Sisli Hamidiye Etfal Training and Research Hospital

Collaborators

Bezmialem Vakif University
Istanbul Training and Research Hospital
Bursa Yüksek İhtisas Education and Research Hospital
Erzincan University
Arnavutkoy State Hospital

Investigators

  • Study Director: Ufuk Oguz Idiz, M.D., Sisli Etfal Training and Research Hospital
  • Principal Investigator: Huseyin Bektasoglu, M.D., Bezmialem Vakif University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2015

Primary Completion (Actual)

October 1, 2017

Study Completion (Actual)

May 1, 2018

Study Registration Dates

First Submitted

January 10, 2016

First Submitted That Met QC Criteria

January 11, 2016

First Posted (Estimate)

January 13, 2016

Study Record Updates

Last Update Posted (Actual)

February 19, 2019

Last Update Submitted That Met QC Criteria

February 16, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sislietfal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Because the time period of this study is very short

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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