Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy (HSTH)
Primary Purpose
CIN, Cancer of Cervix, Cervicitis
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Cervical biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for CIN
Eligibility Criteria
Inclusion Criteria:
- all symptomatizing patients following supracervical hysterectomy,
Exclusion Criteria:
- with total hysterectomy,
- hysterectomies for malignant indications,
- refusal to participate.
Sites / Locations
- Ayman Shehata Dawood
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Biopsy
Arm Description
four quadrant biopsy
Outcomes
Primary Outcome Measures
Detection of cervical neoplasia or cancer incidence
Detection of number of cases diagnosed with cervical Cervical intraepithelial neoplasia, or malignancy by histopathological examination
Detection of chronic cervicitis incidence
Detection of number of cases diagnosed with inflammatory cells and other markers of inflammation
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04809727
Brief Title
Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy
Acronym
HSTH
Official Title
Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
January 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CIN, Cancer of Cervix, Cervicitis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All patients suffering after supracervical hysterectomy
Masking
None (Open Label)
Allocation
N/A
Enrollment
88 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Biopsy
Arm Type
Experimental
Arm Description
four quadrant biopsy
Intervention Type
Procedure
Intervention Name(s)
Cervical biopsy
Intervention Description
4 quadrant biopsy
Primary Outcome Measure Information:
Title
Detection of cervical neoplasia or cancer incidence
Description
Detection of number of cases diagnosed with cervical Cervical intraepithelial neoplasia, or malignancy by histopathological examination
Time Frame
1 year
Title
Detection of chronic cervicitis incidence
Description
Detection of number of cases diagnosed with inflammatory cells and other markers of inflammation
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
all symptomatizing patients following supracervical hysterectomy,
Exclusion Criteria:
with total hysterectomy,
hysterectomies for malignant indications,
refusal to participate.
Facility Information:
Facility Name
Ayman Shehata Dawood
City
Tanta
State/Province
Gharbia
ZIP/Postal Code
31111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy
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