NCT04809727

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
Last Updated

April 6, 2021

Status Verified

April 1, 2021

Enrollment Period

3.1 years

First QC Date

March 13, 2021

Last Update Submit

April 4, 2021

Conditions

CINCancer of CervixCervicitis

Outcome Measures

Primary Outcomes (2)

  • 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

  • Detection of chronic cervicitis incidence

    Detection of number of cases diagnosed with inflammatory cells and other markers of inflammation

    1 year

Study Arms (1)

Biopsy

EXPERIMENTAL

four quadrant biopsy

Procedure: Cervical biopsy

Interventions

Cervical biopsyPROCEDURE

4 quadrant biopsy

Biopsy

Eligibility Criteria

Age40 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • all symptomatizing patients following supracervical hysterectomy,

You may not qualify if:

  • with total hysterectomy,
  • hysterectomies for malignant indications,
  • refusal to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayman Shehata Dawood

Tanta, Gharbia Governorate, 31111, Egypt

Location

MeSH Terms

Conditions

Uterine Cervical NeoplasmsUterine Cervicitis

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: All patients suffering after supracervical hysterectomy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

March 13, 2021

First Posted

March 22, 2021

Study Start

December 1, 2017

Primary Completion

December 31, 2020

Study Completion

January 31, 2021

Last Updated

April 6, 2021

Record last verified: 2021-04

Locations

EG(1)