Histopathological Findings in Symptomatizing Patients Aft... | NCT04809727

Studies
Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy

NCT04809727

Sponsor

Tanta University

Status

Completed

Last Update Posted

Apr 6, 2021Actual

Enrollment

88Actual

Phase

Not Applicable

Conditions

CIN
Cancer of Cervix
Cervicitis

Interventions

Cervical biopsy

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2017Actual

Primary Completion Date

Dec 31, 2020Actual

Completion Date

Jan 31, 2021Actual

First Submitted Date

Mar 13, 2021

First Submission Date that Met QC Criteria

Mar 18, 2021

First Posted Date

Mar 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 4, 2021

Last Update Posted Date

Apr 6, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed 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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Biopsy	Experimental	four quadrant biopsy	Procedure: Cervical biopsy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Cervical biopsy	Procedure	4 quadrant biopsy	Biopsy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

all symptomatizing patients following supracervical hysterectomy,

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Ayman Shehata Dawood		Tanta	Gharbia Governorate	31111	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D002583	Uterine Cervical Neoplasms
D002575	Uterine Cervicitis

Ancestor Terms

ID	Term
D014594	Uterine Neoplasms
D005833	Genital Neoplasms, Female
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site

Browse Leaves

Not provided

Browse Branches

Not provided