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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04809727
Other study ID # HistopathSTH
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2017
Est. completion date January 31, 2021

Study information

Verified date April 2021
Source Tanta University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy was done and histopathological examinations were done to evaluate the pathology in these patients.


Description:

- Study design and settings: Cross sectional descriptive studies conducted from December 2017 till January 2021. - Patients: 80 patients with supracervical hysterectomy recruited at Tanta University Hospital, gynecology clinics will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The exclusion criteria were patients with total hysterectomy, hysterectomies for malignant indications, and refusal to participate. - Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint. Intervention: under general anesthesia cervical biopsy (4 quadrants) were taken from all patients and was sent for histopathological examinations.


Recruitment information / eligibility

Status Completed
Enrollment 88
Est. completion date January 31, 2021
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender Female
Age group 40 Years and older
Eligibility Inclusion Criteria: - all symptomatizing patients following supracervical hysterectomy, Exclusion Criteria: - with total hysterectomy, - hysterectomies for malignant indications, - refusal to participate.

Study Design


Intervention

Procedure:
Cervical biopsy
4 quadrant biopsy

Locations

Country Name City State
Egypt Ayman Shehata Dawood Tanta Gharbia

Sponsors (1)

Lead Sponsor Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Detection of cervical neoplasia or cancer incidence Detection of number of cases diagnosed with cervical Cervical intraepithelial neoplasia, or malignancy by histopathological examination 1 year
Primary Detection of chronic cervicitis incidence Detection of number of cases diagnosed with inflammatory cells and other markers of inflammation 1 year
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