LLETZ Under Direct Colposcopic Vision

Uterine Cervical Dysplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910388
• Other study ID #: CONE-3
• Status: Completed
• Phase: N/A
• Start date: October 2016
• Est. completion date: December 2017

Study information

• Verified date: December 2017
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Device:
• LLETZ with colposcopy
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue

Other:
• LLETZ without colposcopy
Loop procedure without using a colposcope

Locations

Country	Name	City	State
Germany	Department of Obstetrics and Gynecology of the Ruhr University Bochum	Herne	NRW

Sponsors (2)

Lead Sponsor	Collaborator
Zydolab - Institute of Cytology and Immune Cytochemistry	Ruhr University of Bochum

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Operative complications	Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively	14 days
Secondary	number of fragments of the surgical specimen	surgeons will count the number of the surgical specimen (1 vs. >1)	10 minutes
Secondary	the dimensions of the surgical specimens	The circumference, length and thickness of The surgical specimens will be measured	2 Days after conization
Secondary	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
Secondary	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
Secondary	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
Secondary	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