LLETZ Under Direct Colposcopic Vision

Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.

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

Study Overview

• Status: Completed
• Conditions: Uterine Cervical Dysplasia
• Intervention / Treatment: Device: LLETZ with colposcopy; Other: LLETZ without colposcopy

• Study Type: Interventional
• Enrollment (Actual): 150
• 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
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: LLETZ with colposcopy; The LLETZ procedure will be performed under direct colposcopic vision	Device: LLETZ with colposcopy; Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
ACTIVE_COMPARATOR: LLETZ without colposcopy; The LLETZ procedure will be performed without colposcopy	Other: LLETZ without colposcopy; Loop procedure without using a colposcope

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
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
the dimensions of the surgical specimens	The circumference, length and thickness of The surgical specimens will be measured	2 Days after conization

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (ACTUAL): December 1, 2017
• Study Completion (ACTUAL): December 1, 2017

Study Registration Dates

• First Submitted: September 15, 2016
• First Submitted That Met QC Criteria: September 21, 2016
• First Posted (ESTIMATE): September 22, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2020
• Last Update Submitted That Met QC Criteria: May 31, 2020
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: randomized controlled trial; colposcopy; conization; LLETZ; intraoperative colposcopy; loop excision; direct colposcopic vision
• 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-3

Plan for Individual participant data (IPD)

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