LLETZ Under Direct Colposcopic Vision

Sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry (Other)

Overall Status

Completed

CT.gov ID

NCT02910388

Collaborator

Ruhr University of Bochum (Other)

150

Enrollment

Location

Arms

Duration (Months)

10.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Dysplasia	Device: LLETZ with colposcopy Other: LLETZ without colposcopy	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2016

Actual Primary Completion Date :

Dec 1, 2017

Actual Study Completion Date :

Dec 1, 2017

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

the resected cone mass [10 minutes]
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room

Secondary Outcome Measures

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