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Comparing two methods of uterus evaluation by hysteroscopy

Phase 3
Not yet recruiting
Conditions
Abnormal uterine and vaginal bleeding, unspecified,
Registration Number
CTRI/2025/05/086218
Lead Sponsor
Dr Bani Gupta
Brief Summary

This thesis protocol aims to compare vaginohysteroscopy with traditional hysteroscopy in terms of efficacy, patient comfort, complications, and procedural ease. Conducted as a randomized clinical trial at Kasturba Hospital, Delhi, it involves 44 women undergoing office hysteroscopy. Vaginohysteroscopy, a less invasive technique that avoids speculum and tenaculum use, is hypothesized to cause less pain, improve patient satisfaction, and reduce complications. The study evaluates success rates, procedure time, pain (VAS), and satisfaction (Likert scale). With ethical approval secured, this research seeks to support a more patient-friendly approach to diagnostic hysteroscopy in gynecological practice.

Detailed Description

Not available

Recruitment & Eligibility

Status
Not Yet Recruiting
Sex
Female
Target Recruitment
44
Inclusion Criteria

Abnormal uterine bleeding Post-menopausal bleeding polyp uterine fibroid.

Exclusion Criteria
  • Pregnant women Cervical cancer Active infection of genital tract Blood dyscrasia and coagulopathy Cannot tolerate a speculum insertion due to vaginismus.
  • Virginal status Having medical conditions making them unfit for anesthesia if need be.
  • Active heavy bleeding.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Primary outcome:Immediate at baseline
Success rate of Vaginohysteroscopy and traditional hysteroscopy which includes ability to enter the uterine cavity and satisfactory evaluation of the uterine cavity.Immediate at baseline
Secondary Outcome Measures
NameTimeMethod
1. Time taken from introduction to entry into cavity till both the ostia are visible & total procedural time for diagnostic procedure.2.Pain assessment using Visual analogue scale which is a 10-point scale with 0= no pain & 10= worst pain.

Trial Locations

Locations (1)

Kasturba Hospital Delhi

🇮🇳

Central, DELHI, India

Kasturba Hospital Delhi
🇮🇳Central, DELHI, India
Dr Bani Gupta
Principal investigator
09873205096
guptabani.bg@gmail.com

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