Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

Zydolab - Institute of Cytology and Immune Cytochemistry

Status: Completed

Conditions: Uterine Cervical Dysplasia

Treatments: Procedure: Loop Excision Procedure; Procedure: Fischer Cone Biopsy Excisor

Study type: Interventional

Funder types: Other

Identifiers

NCT02515162

CONE-2

Details and patient eligibility

About

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.

Full 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.

Enrollment: 178 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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178 participants in 2 patient groups

Fischer Cone Biopsy Excisor

Experimental group

Description:

Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor

Treatment:

Procedure: Fischer Cone Biopsy Excisor

Loop Excision Procedure

Active Comparator group

Description:

Conization Methode using a circular electrode , i.e. Loop excision Procedure

Treatment:

Procedure: Loop Excision Procedure