LLETZ Under Direct Colposcopic Vision

NCT02910388 | Completed

• 1 other identifier: CONE-3
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.

Conditions

Uterine Cervical Dysplasia

Keywords

conization; LLETZ; loop excision; randomized controlled trial; colposcopy; direct colposcopic vision; intraoperative colposcopy

Outcome Measures

Primary Outcomes (1)

• the resected cone mass

  the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

  10 minutes

Secondary Outcomes (9)

• Margin status

  2 Days after conization

• Operation time

  20 minutes

• Operative complications

  14 days

• number of fragments of the surgical specimen

  10 minutes

• the dimensions of the surgical specimens

  2 Days after conization

Study Arms (2)

LLETZ with colposcopy

EXPERIMENTAL

The LLETZ procedure will be performed under direct colposcopic vision

Device: LLETZ with colposcopy

LLETZ without colposcopy

ACTIVE COMPARATOR

The LLETZ procedure will be performed without colposcopy

Other: LLETZ without colposcopy

Interventions

LLETZ with colposcopy DEVICE

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

LLETZ with colposcopy

LLETZ without colposcopy OTHER

Loop procedure without using a colposcope

LLETZ without colposcopy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• significant language barrier
• a personal history of conization
• pregnancy
• the use of blood thinner
• unwillingness to participate

Sponsors & Collaborators

• Zydolab - Institute of Cytology and Immune Cytochemistry: lead
• Ruhr University of Bochum: collaborator

Study Sites (1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Interventions

Colposcopy

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Obstetrical and Gynecological; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Obstetric Surgical Procedures; Gynecologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Ziad Hilal, M.D.

  Zydolab - Institute of Cytology and Immune Cytochemistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2016
• First Posted: September 22, 2016
• Study Start: October 1, 2016
• Primary Completion: December 1, 2017
• Study Completion: December 1, 2017
• Last Updated: June 2, 2020

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)