LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy

NCT ID: NCT04326049

Last Updated: 2022-07-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

227 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-25

Study Completion Date

2021-06-29

Brief Summary

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To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.

Detailed Description

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Conditions

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Uterine Cervical Dysplasia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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LLETZ with videocolposcopy

The LLETZ procedure will be performed using a videocolposcopy

Group Type EXPERIMENTAL

LLETZ with videocolposcope

Intervention Type DEVICE

Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue

LLETZ with binocular colposcopy

The LLETZ procedure will be performed using a binocular colposcope

Group Type ACTIVE_COMPARATOR

LLETZ with binocular colposcope

Intervention Type DEVICE

Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue

Interventions

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LLETZ with videocolposcope

Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue

Intervention Type DEVICE

LLETZ with binocular colposcope

Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* histologically proven cervical dysplasia
* colposcopy Prior to conization
* informed consent

Exclusion Criteria

* significant language barrier
* a personal history of conization
* pregnancy
* the use of blood thinner
* unwillingness to participate
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ruhr University of Bochum

OTHER

Sponsor Role collaborator

Zydolab - Institute of Cytology and Immune Cytochemistry

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ziad Hilal, M.D.

Role: PRINCIPAL_INVESTIGATOR

Zydolab - Institute of Cytology and Immune Cytochemistry

Locations

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Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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Rezniczek GA, Neghabian N, Rehman S, Tempfer CB. Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial. Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21.

Reference Type DERIVED
PMID: 34802113 (View on PubMed)

Other Identifiers

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CONE-5

Identifier Type: -

Identifier Source: org_study_id

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