NCT04387123

Brief Summary

Vaginoscopic examination is usually difficult due to continuous leakage of the distension medium from the introitus. This study aims to assess the effectiveness and success of performing diagnostic or operative vaginoscopic surgery via a tight self-retaining external vulvar sheet (Darwish sheet) expressed as tight vaginoscopy (TV) compared with conventional vaginoscopy (CV).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Longer than P75 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

July 1, 2014

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 8, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 13, 2020

Completed
Last Updated

May 13, 2020

Status Verified

May 1, 2020

Enrollment Period

5.5 years

First QC Date

May 8, 2020

Last Update Submit

May 12, 2020

Conditions

Vaginoscopy

Keywords

vaginoscopyDarwish sheetVaginacervixvirginnullipra

Outcome Measures

Primary Outcomes (3)

  • clarity of visualization of the vagina and the cervix

    clear

    1 day

  • estimation of infused and leaked distension medium before and after application of vulvar Darwish sheet

    1 day

  • the success rate of operative TV whenever indicated

    1 day

Study Arms (2)

Conventional vaginoscopy

ACTIVE COMPARATOR

Vaginoscopy without vulvar tightness

Procedure: Vaginoscopy

Tight vaginoscopy

ACTIVE COMPARATOR

Vaginoscopy via Darwish sheet

Procedure: Vaginoscopy

Interventions

VaginoscopyPROCEDURE

Vaginoscopic examination and possible operative endoscopic management

Conventional vaginoscopyTight vaginoscopy

Eligibility Criteria

Age4 Years - 25 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • children, adolescents nulliparous adult females scheduled for vaginoscopy Suspected vaginal or cervical lesion or foreign body FB

You may not qualify if:

  • Multiparous patients nulliparous patients with normal, patulous or lax vaginas

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Woman's Health University Hospital

Asyut, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Vaginoscopy via Darwish sheet or without its use.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

May 8, 2020

First Posted

May 13, 2020

Study Start

July 1, 2014

Primary Completion

January 1, 2020

Study Completion

May 1, 2020

Last Updated

May 13, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)