Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

Uterine Cervical Dysplasia Clinical Trial

Official title:

Fischer Cone Biopsy Excisor Versus Loop Excision Procedure. A Randomized Trial of Two Operation Techniques in Women Undergoing Conization for Cervical Dysplasia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02515162
• Other study ID #: CONE-2
• Status: Completed
• Phase: N/A
• First received: July 28, 2015
• Last updated: August 13, 2016
• Start date: July 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Zydolab - Institute of Cytology and Immune Cytochemistry
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial Summary

In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure, will be compared. The primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.

Description:

Conization is the method of choice in therapy for cervical dysplasia. Beside the risk of preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection margin is high.

The Goldstandard standard technique in conization for women with cervical dysplasia is the large loop excision of the transformation zone ("LLETZ"). Nevertheless other techniques such as the excision of the abnormal tissue with the so called "Fischer Cone Biopsy Excisor" could provide advantages and is yet not enough investigated. The loop excision technique uses a circular electrode, in contrast Fischer Cone Biopsy Excision is done by a triangular electrode.

It is unknown, whether the use of the circular or the triangular electrode is superior regarding the dysplasia-free resection margin rate and other outcome parameters such as the resected cone volume, postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, comparing the two electrosurgical techniques, "LLETZ-conization" and "Fischer Cone Biopsy Excision". The primary outcome of the study is the dysplasia-free resection margin rate independently proved by a pathologist, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 11 step VAS scale, time to complete hemostasis measured in seconds, duration of the intervention measured in minutes, resected cone volume, users satisfaction according to a 11 step VAS scale and intra- and postoperative complications, defined as necessity to intervene surgically up to 14 days postoperatively.

The study Population consists of women undergoing conization for histologically proven cervical dysplasia.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 178
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• 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

• no known hematologic disorder

Exclusion Criteria:

• significant language barrier

• a personal history of conization

• pregnancy

• the use of blood thinner

• unwillingness to participate

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervical Intraepithelial Neoplasia
• Uterine Cervical Dysplasia

Intervention

Procedure:
• Fischer Cone Biopsy Excisor
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
• Loop Excision Procedure
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone

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, 

References & Publications (6)

Bevis KS, Biggio JR. Cervical conization and the risk of preterm delivery. Am J Obstet Gynecol. 2011 Jul;205(1):19-27. doi: 10.1016/j.ajog.2011.01.003. Epub 2011 Feb 23. Review. — View Citation

Boardman LA, Steinhoff MM, Shackelton R, Weitzen S, Crowthers L. A randomized trial of the Fischer cone biopsy excisor and loop electrosurgical excision procedure. Obstet Gynecol. 2004 Oct;104(4):745-50. — View Citation

Jin G, LanLan Z, Li C, Dan Z. Pregnancy outcome following loop electrosurgical excision procedure (LEEP) a systematic review and meta-analysis. Arch Gynecol Obstet. 2014 Jan;289(1):85-99. doi: 10.1007/s00404-013-2955-0. Epub 2013 Jul 11. Review. — View Citation

Khalid S, Dimitriou E, Conroy R, Paraskevaidis E, Kyrgiou M, Harrity C, Arbyn M, Prendiville W. The thickness and volume of LLETZ specimens can predict the relative risk of pregnancy-related morbidity. BJOG. 2012 May;119(6):685-91. doi: 10.1111/j.1471-0528.2011.03252.x. Epub 2012 Feb 14. — View Citation

Mathevet P, Chemali E, Roy M, Dargent D. Long-term outcome of a randomized study comparing three techniques of conization: cold knife, laser, and LEEP. Eur J Obstet Gynecol Reprod Biol. 2003 Feb 10;106(2):214-8. — View Citation

Shaco-Levy R, Eger G, Dreiher J, Benharroch D, Meirovitz M. Positive margin status in uterine cervix cone specimens is associated with persistent/recurrent high-grade dysplasia. Int J Gynecol Pathol. 2014 Jan;33(1):83-8. doi: 10.1097/PGP.0b013e3182763158. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
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	No
Secondary	Postoperative pain	patients will score their postoperative pain Level using a 11-step visual analogue scale (nVAS) and a 5-step graphical visual analogue scale (gVAS)within 5 hours after surgery	5 hours	No
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	No
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	No
Secondary	Resected cone volume	The resected cone volume will be measured postoperative by using a scale	10 minutes	No
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	No
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	No
Secondary	Operative complications	Operative complications defined as necessity to intervene surgically up to 14 days postoperatively	14 days	Yes
Secondary	number of fragments of the surgical specimen	surgeons will count the number of the surgical specimen (1 vs. >1)	10 minutes	No