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Completed

NCT Number: NCT04326049

LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy

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

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

LLETZ with videocolposcope

Device

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

LLETZ with binocular colposcope

Device

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

Primary outcomes

  1. the resected cone mass

    Time frame: 10 minutes

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

Secondary outcomes

  1. Margin status

    Time frame: 2 Days after conization

    Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist

  2. Operation time

    Time frame: 20 minutes

    the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes

  3. Operative complications

    Time frame: 14 days

    Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively

  4. number of fragments of the surgical specimen

    Time frame: 10 minutes

    surgeons will count the number of the surgical specimen (1 vs. >1)

  5. The circumference of the surgical specimens

    Time frame: 2 Days after conization

    The circumference of the surgical specimens will be measured in cm

  6. the length of the surgical specimens

    Time frame: 2 Days after conization

    The length of The surgical specimens will be measured in cm

  7. the thickness of the surgical specimens

    Time frame: 2 Days after conization

    The thickness of The surgical specimens will be measured in cm

  8. handling of the device

    Time frame: 30 minutes

    surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')

  9. satisfaction with the device

    Time frame: 30 minutes

    surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')

  10. Time to complete intraoperative hemostasis

    Time frame: 120 seconds

    the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

  11. Intraoperative blood loss

    Time frame: 5 hours

    intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Collaborators

  • Ruhr University of Bochum

Registry information

Official study title

Performance of Large Loop Excision of the Transformation Zone Using Videocolposcopy Versus Binocular Colposcopy in Women With Cervical Dysplasia: a Randomized Controlled Trial.

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Jul 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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