LLETZ Under Direct Colposcopic Vision

Not Applicable

Completed

• Conditions: Uterine Cervical Dysplasia

• Registration Number: NCT02910388
• Lead Sponsor: Zydolab - Institute of Cytology and Immune Cytochemistry

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-21
• Study First Posted: 2016-09-22
• Study Start: 2016-10
• Status Verified: 2017-12
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Last Update Submitted: 2020-05-31
• Last Update Posted: 2020-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Operative complications	14 days	Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
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
number of fragments of the surgical specimen	10 minutes	surgeons will count the number of the surgical specimen (1 vs. \>1)
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')
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
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')
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
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

Trial Locations

Locations (1)

Department of Obstetrics and Gynecology of the Ruhr University Bochum; 🇩🇪 Herne, NRW, Germany