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

NCT03024242 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2017-01-24

No results posted yet for this study

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.

Conditions

  • Endosalpingiosis

Interventions

DEVICE

Tight vaginoscope

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
NA
Purpose
PREVENTION
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2016-12-31
Completion
2017-01-31

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03024242 on ClinicalTrials.gov