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