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Clinical Trials/NCT04917341
NCT04917341
Completed
Not Applicable

The Compatibility of Preoperative Endometrial Biopsies With Postoperative Final Pathology in Endometrial Cancer; Should Preoperative Pathology Samples of Patients Referred to a Tertiary Center be Re-evaluated?

Batman Training and Research Hospital0 sites960 target enrollmentApril 12, 2002

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Endometrial Cancer Stage
Sponsor
Batman Training and Research Hospital
Enrollment
960
Primary Endpoint
Comparison of endometrial sampling results performed in 2 different centers
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Although there are many studies comparing preoperative and postoperative histological diagnoses in the literature, there are no studies evaluating the compatibility of preoperative histological diagnoses obtained from different centers with postoperative histological diagnoses.Therefore, in our study, we aimed to determine whether preoperative pathological specimens need to be re-evaluated in the referenced hospitals by comparing the compatibility of endometrial specimens in secondary care and tertiary centers with their final pathologies.In our study, we aimed to reveal the under and overdiagnosis rates of the preoperative histological diagnoses of our hospitals compared to the final pathology.

Detailed Description

Medical data of 960 patients diagnosed with endometrial cancer by endometrial biopsy between 2002 and 2016 were retrospectively analyzed. Of these patients, 41 were excluded from the study due to non-surgical treatment, 254 patients having biopsy only in one center preoperatively, and lack of medical data in 52 patients.The study included 613 patients who had preoperative endometrial biopsy specimens evaluated by two different centers, diagnosed with endometrial cancer and treated surgically. Our study was conducted in the gynecological oncology department of our university after obtaining the approval of the ethics committee numbered 430-2019.The clinicopathological characteristics of the patients were evaluated by examining the hospital records of age, gravida, parity, BM (body mass index), menopausal status and systemic diseases. Histopathological and clinical features of endometrial cancer were reviewed.In this study, endometrial biopsy samples taken in the second stage state hospital were re-evaluated by the gynecopathologist working at the university hospital and / or the evaluation process was carried out in two steps by examining the repeated endometrial biopsy sampling.Patients diagnosed with endometrial cancer were treated surgically in our clinic. Endometrial sampling results based on uterine cancer risk groups; While histologically endometrioid and nonendometrioid were evaluated in two groups, the greade1-2 (low risk), greade3 (high risk) of uterine cancer were evaluated in four groups as those without malingnancy (benign and premaling lesions).By comparing these preoperative histological diagnoses with postoperative surgical final pathology, the accuracy rates for histological type and greade were determined. In addition, lower diagnosis, comorbidity and higher diagnosis rates compared to final pathology were examined for two different centers.

Registry
clinicaltrials.gov
Start Date
April 12, 2002
End Date
May 27, 2021
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Batman Training and Research Hospital
Responsible Party
Principal Investigator
Principal Investigator

Erhan Okuyan,M.D

M.D

Batman Training and Research Hospital

Eligibility Criteria

Inclusion Criteria

  • Female patients aged 40-90 years diagnosed with endometrial cancer according to
  • endometrial sampling results

Exclusion Criteria

  • Lack of medical data
  • Endometrial sampling in only one center

Outcomes

Primary Outcomes

Comparison of endometrial sampling results performed in 2 different centers

Time Frame: 1 year

in our study, we aimed to determine whether preoperative pathological specimens need to be re-evaluated in the referenced hospitals by comparing the compatibility of endometrial specimens in secondary care and tertiary centers with their final pathologies.

Secondary Outcomes

  • To reveal the rates of under and overdiagnosis of preoperative histological results(1 year)

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