LLETZ With Videocolposcopy Versus LLETZ With Binocular Colposcopy

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

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

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Dysplasia
• Intervention / Treatment: Device: LLETZ with videocolposcope; Device: LLETZ with binocular colposcope

• Study Type: Interventional
• Enrollment (Actual): 227
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • NRW
    • Herne, NRW, Germany, 44625
      • Department of Obstetrics and Gynecology of the Ruhr University Bochum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LLETZ with videocolposcopy; The LLETZ procedure will be performed using a videocolposcopy	Device: LLETZ with videocolposcope; Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue
Active Comparator: LLETZ with binocular colposcopy; The LLETZ procedure will be performed using a binocular colposcope	Device: LLETZ with binocular colposcope; Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Margin status	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 Days after conization
Operation time	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	20 minutes
Operative complications	Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively	14 days
number of fragments of the surgical specimen	surgeons will count the number of the surgical specimen (1 vs. >1)	10 minutes
The circumference of the surgical specimens	The circumference of the surgical specimens will be measured in cm	2 Days after conization
the length of the surgical specimens	The length of The surgical specimens will be measured in cm	2 Days after conization
the thickness of the surgical specimens	The thickness of The surgical specimens will be measured in cm	2 Days after conization
handling of the device	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')	30 minutes
satisfaction with the device	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')	30 minutes
Time to complete intraoperative hemostasis	the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds	120 seconds
Intraoperative blood loss	intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively	5 hours

Collaborators and Investigators

• Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry
• Collaborators: Ruhr University of Bochum

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2020
• Primary Completion (Actual): March 28, 2021
• Study Completion (Actual): June 29, 2021

Study Registration Dates

• First Submitted: March 25, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 30, 2020

Study Record Updates

• Last Update Posted (Actual): July 19, 2022
• Last Update Submitted That Met QC Criteria: July 17, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; colposcopy; conization; LLETZ; binocular colposcopy; intraoperative colposcopy; videocolposcopy; loop excision
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Precancerous Conditions; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Uterine Cervical Dysplasia
• Other Study ID Numbers: CONE-5

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No