Uterine Cervical Dysplasia
Conditions
Keywords
conization, LLETZ, cervical dysplasia, cervical intraepithelial neoplasia
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.
Interventions
PROCEDURESpray
surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage
PROCEDUREForced
surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage
Sponsors
Ruhr University of Bochum
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time to complete intraoperative hemostasis | 120 seconds | the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| postoperative pain | 5 hours | patients will score their postoperative pain Level using a 10-step visual analogue scale (VAS) within 5 hours after surgery |
| postoperative complications | 14 days | postoperative complications defined as the necessity to intervene surgically for vaginal bleeding within 14 days after surgery |
| intraoperative blood loss | 5 hours | intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively |
Countries
Germany
Outcome results
None listed