Gynecological Presentations Following Supracervical Hyste... | NCT03606772

Studies
Gynecological Presentations Following Supracervical Hysterectomy

NCT03606772

Sponsor

Tanta University

Status

Completed

Last Update Posted

Jun 12, 2019Actual

Enrollment

130Actual

Phase

Not provided

Conditions

Gynecological Survey

Interventions

Questionanniare

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

Jun 2019

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

Aug 1, 2018Actual

Primary Completion Date

Mar 31, 2019Actual

Completion Date

Mar 31, 2019Actual

First Submitted Date

Jul 22, 2018

First Submission Date that Met QC Criteria

Jul 27, 2018

First Posted Date

Jul 31, 2018Actual

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

Jun 9, 2019

Last Update Posted Date

Jun 12, 2019Actual

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 will be done and histopathological examinations will be done to evaluate the pathology in these patients.

Detailed Description

Study design and settings: Cross sectional descriptive studies
Patients: 130 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The
Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

15 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

130Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
supracervical hysterectomy		Patients operated abdominal by removal of uterus, with removal of tubes and ovaries and retaining of cervix	Other: Questionanniare

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Questionanniare	Other	Filling printed questionnaire + Pelvic examination	supracervical hysterectomy

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
number of participant with gynecological symptoms following hysterectomy	Symptoms occurring after hysterectomy	6 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hysterectomy for benign pathologies

Exclusion Criteria:

Hysterectomy for malignancy

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

ID cards

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

• Patients: 1280 patients with hysterectomy recruited at Tanta University Hospital, gynecology clinics in central hospitals in Gharbia governorate

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ayman Dawood	Lecturer at Tanta University	Principal Investigator

Locations

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

IPD Sharing Statement Module

Plan to Share IPD

Description

Patients data are not allowed to be public

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided