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Clinical Trials/NCT03024242
NCT03024242
Completed
Phase 2

Tight Vaginoscopy: a Simplified Novel Technique for a Better Vaginal Surgery

Assiut University1 site in 1 country34 target enrollmentJuly 2014

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Endosalpingiosis
Sponsor
Assiut University
Enrollment
34
Locations
1
Primary Endpoint
The success rate of the procedure
Status
Completed
Last Updated
9 years ago

Overview

Brief Summary

Bivalve vaginal speculum insertion is a basic final step of vaginal examination. Unfortunately, it can't be inserted in young girls, virgins, nulliparous women with narrow vagina, women with vaginismus or patients with a history of previous vaginal surgery. In such cases, the value of vaginoscopy (examination of the vagina without speculum) is evident. Indications of vaginoscopy are expanding. In addition to confirmation of suspected vaginal masses or polypi diagnosis, it can be used to diagnose laceration of the vaginal wall in girls due to foreign body , traumatic injuries or sexual abuse. In a systematic review, the effectiveness and feasibility of using hysteroscopy for exploration of the immature genital tract (vaginoscopy) were documented.It may help in the diagnosis and treatment of gynecologic disorders in adolescent patients with an intact hymen, limited vaginal access, or a narrow vagina. Another recent systematic review highlighted the importance of Vagino-hysteroscopy as an easy way to gain access to the cervical canal and an important tool with which to diagnose and treat vaginal lesions.

In practice, we notice leakage of excessive irrigating fluid per vagina with poor visualization during vaginoscopy. To the best of our knowledge, no study addressed a solution to improve visualization and success of vaginoscopic surgery. This study aims to test feasibility and doctor satisfaction of performing conventional diagnostic vaginoscopy if compared to tight diagnostic vaginoscopy and success on performing tight vaginoscopic surgery in patients with vaginal or cervical lesions.

Registry
clinicaltrials.gov
Start Date
July 2014
End Date
January 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Khairy Ali

Lecturer

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Symptomatizing women with suspected narrow vagina.
  • Nulliparous women or virgin w
  • Vaginal or cervical lesion or foreign body.

Exclusion Criteria

  • Multiparous women
  • Nulliparous women with patulous or lax vaginae were excluded.

Outcomes

Primary Outcomes

The success rate of the procedure

Time Frame: 20 minutes

Secondary Outcomes

  • The satisfaction rate by satisfaction score(20 minutes)

Study Sites (1)

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