Brief Title
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial
Official Title
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial
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.
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.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
time to complete intraoperative hemostasis
Secondary Outcome
postoperative pain
Condition
Uterine Cervical Dysplasia
Intervention
Spray
Study Arms / Comparison Groups
Spray
Description: cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
160
Start Date
January 2014
Completion Date
March 2015
Primary Completion Date
March 2015
Eligibility 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
Gender
Female
Ages
18 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Clemens B Tempfer, MD, ,
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT02330471
Organization ID
CONE-1
Responsible Party
Principal Investigator
Study Sponsor
Ruhr University of Bochum
Study Sponsor
Clemens B Tempfer, MD, Principal Investigator, Ruhr University Bochum
Verification Date
April 2015