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Establishing the "See and Treat approach" in Pre-cancerous lesions of cervix

"See and Treat " approach vs "Three step approach" in treatment of pre-invasive lesions of cervix : A randomized control trial

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025241
Enrollment
100
Registered
2020-05-19
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N879- Dysplasia of cervix uteri, unspecified

Interventions

Intervention1: colposcopy followed by treatment of the abnormal suspected lesion: treatment using a) LEEP B) cold knife conisation C) thermal ablation LEEP and Thermal ablation are day care procedures

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: Women aged 25-60 years suspected to have Cervical intraepithelial neoplasia on PAP Smear/Colposcopy/Clinical examination will be included in the study. Women with abnormal screening results (PAP smear with Atypical squamous cells of undetermined significance (ASCUS) or worse , positive HPV DNA, positive VIA or visual inspection with Lugolâ??s iodine) Women with clinically abnormal cervix with normal PAP smear Women with persistent inflammatory PAP smears, post coital bleeding or persistent discharge P/V

Exclusion criteria

Exclusion criteria: Inability to give informed consent Women with obvious growth on cervix. Pregnant women Women with severe debilitating disease Women with history of pelvic irradiation

Design outcomes

Primary

MeasureTime frame
To compare the results in the two treated groups , one by â??See and Treatâ?? approach and one by conventional three step approach, in terms of initial cytology, final Histopathological diagnosis, LEEP resultsTimepoint: initially, 10 days , 6 months, 1 year

Secondary

MeasureTime frame
To compare the two colposcopy scoring systems, the Reid Colposcopy Index(RCI) and the Swede Score in terms of their specificity, sensitivity, negative predictive value and positive predictive values.Timepoint: AT baseline

Countries

India

Contacts

Public ContactDr Jaya Chaturvedi

AIIMS Rishikesh

jaya_sunil@yahoo.com9997310120

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026