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NCT Number: NCT02515162

Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

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.

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Key information

Conditions

Uterine Cervical Dysplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Department of Obstetrics and Gynecology of the Ruhr University Bochum

Herne, North Rhine-Westphalia, 44625, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fischer Cone Biopsy Excisor

Procedure

Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone

Loop Excision Procedure

Procedure

Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone

Primary outcomes

  1. Margin status

    Time frame: 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

Secondary outcomes

  1. Intraoperative blood loss

    Time frame: 5 hours

    intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively

  2. Postoperative pain

    Time frame: 5 hours

    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

  3. Time to complete intraoperative hemostasis

    Time frame: 120 seconds

    the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds

  4. Operation time

    Time frame: 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

  5. Resected cone volume

    Time frame: 10 minutes

    The resected cone volume will be measured postoperative by using a scale

  6. satisfaction with the device

    Time frame: 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')

  7. handling of the device

    Time frame: 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')

  8. Operative complications

    Time frame: 14 days

    Operative complications defined as necessity to intervene surgically up to 14 days postoperatively

  9. number of fragments of the surgical specimen

    Time frame: 10 minutes

    surgeons will count the number of the surgical specimen (1 vs. >1)

Sponsors and collaborators

Lead sponsor

Zydolab - Institute of Cytology and Immune Cytochemistry

Other

Collaborators

  • Ruhr University of Bochum

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 4, 2015
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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