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

Study Overview
=================
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.

Official Title
-----------------
Forced Versus Spray Coagulation in Women Undergoing LLETZ-conization for Cervical Dysplasia: a Randomized Trial

Conditions
-----------------
Uterine Cervical Dysplasia

Intervention / Treatment
-----------------
* Procedure: Spray
* Procedure: Forced


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spray<br>cervical coagulation using a superficial electrical coagulation mode, ie spray coagulation | Procedure: Spray<br>* surgical method to achieve intraoperative hemostasis by a superficial electrocoagulation of 80 Watt voltage<br>|
| Active Comparator: Forced<br>cervical coagulation using a deep tissue electrical coagulation mode, ie forced coagulation | Procedure: Forced<br>* surgical method to achieve intraoperative hemostasis by a deep tissue electrocoagulation of 80 Watt voltage<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to complete intraoperative hemostasis | the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds | 120 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | patients will score their postoperative pain Level using a 10-step visual analogue scale (VAS) within 5 hours after surgery | 5 hours | 
| postoperative complications | postoperative complications defined as the necessity to intervene surgically for vaginal bleeding within 14 days after surgery | 14 days | 
| intraoperative blood loss | intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively | 5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
conization, LLETZ, cervical dysplasia, cervical intraepithelial neoplasia