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Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial (CONE-1)

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ClinicalTrials.gov Identifier: NCT02330471
Recruitment Status : Completed
First Posted : January 5, 2015
Last Update Posted : April 17, 2015
Sponsor:
Information provided by (Responsible Party):
Clemens Tempfer, Ruhr University of Bochum

Brief Summary:
In a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, two coagulation modes, spray versus forced coagulation, will be compared. The primary outcome of the study is time to complete hemostasis, secondary outcomes are intraoperative blood loss, postoperative pain, and postoperative bleeding complications.

Condition or disease Intervention/treatment Phase
Uterine Cervical Dysplasia Procedure: Spray Procedure: Forced Phase 3

Detailed Description:
Intraoperative bleeding during large loop excision of the transformation zone (LLETZ)-conization can be achieved by two modes of electrocoagulation, spray coagulation and forced coagulation. Spray coagulation is a superficial coagulation mode, whereas forced coagulation is a deep tissue coagulation mode. It is unknown, whether spray or forced coagulation is superior regarding intraoperative hemostasis and other outcome Parameters such as postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 120 women undergoing large loop excision of the transformation zone (LLETZ)-conization for cervical dysplasia, comparing the two coagulation modes, spray coagulation and forced coagulation, The primary outcome of the study is time to complete hemostasis measured in seconds, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 10 step VAS scale, and postoperative bleeding complications, defined as necessity to intervene surgically for vaginal bleeding up to 14 days postoperatively. The study Population consists of women undergoing LLETZ-conization for histologically proven cervical dysplasia. The study hypothesis states that the difference in the mean time until complete hemostais will be at least 1/3 shorter in women randomized to spray coagulation. With a study Population of 120 women, this study has a power of >80% to detect a difference of 1/3 of the mean coagulation time until complete hemostais based on an anticipated mean time of 85 seconds.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial
Study Start Date : January 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Spray
cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation
Procedure: Spray
surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage

Active Comparator: Forced
cervical coagulation using a deep tissue electrical coagulation mode, ie forced coagulation
Procedure: Forced
surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. postoperative pain [ Time Frame: 5 hours ]
    patients will score their postoperative pain Level using a 10-step visual analogue scale (VAS) within 5 hours after surgery

  2. postoperative complications [ Time Frame: 14 days ]
    postoperative complications defined as the necessity to intervene surgically for vaginal bleeding within 14 days after surgery

  3. 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



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • histologically proven cervical dysplasia
  • colposcopy Prior to LLETZ-conization
  • informed consent
  • no known hematologic disorder

Exclusion Criteria:

  • significant language barrier
  • a personal history of LLETZ-conization

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02330471


Locations
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Germany
Ruhr University Bochum
Bochum, Germany, 44625
Sponsors and Collaborators
Ruhr University of Bochum
Investigators
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Principal Investigator: Clemens B Tempfer, MD Ruhr University Bochum

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Clemens Tempfer, Clemens Tempfer, MD, Ruhr University of Bochum
ClinicalTrials.gov Identifier: NCT02330471     History of Changes
Other Study ID Numbers: CONE-1
First Posted: January 5, 2015    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015
Keywords provided by Clemens Tempfer, Ruhr University of Bochum:
conization
LLETZ
cervical dysplasia
cervical intraepithelial neoplasia
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Hyperplasia
Pathologic Processes
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type