Clinical trial NCT02330471: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Uterine Cervical Dysplasia
Keywords: conization
LLETZ
cervical dysplasia
cervical intraepithelial neoplasia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: time to complete intraoperative hemostasis
timeFrame: 120 seconds
Secondary outcomes:
measure: postoperative pain
timeFrame: 5 hours
measure: postoperative complications
timeFrame: 14 days
measure: intraoperative blood loss
timeFrame: 5 hours
Other outcomes:
Locations:
city: Bochum
country: Germany
facility: Ruhr University Bochum
Study officials:
affiliation: Ruhr University Bochum
name: Clemens B Tempfer, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hilal Z, Mavrommati G, Foerster C, Rezniczek GA, Hefler LA, Tempfer CB. Spray Versus Forced Coagulation in Large Loop Excision of the Transformation Zone: A Randomized Trial. J Low Genit Tract Dis. 2016 Apr;20(2):169-73. doi: 10.1097/LGT.0000000000000177.