Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two
 electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure,
 will be compared. The primary outcome of the study is dysplasia-free resection margin rate,
 secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention
 time, postoperative pain, intra- and postoperative complications, the resected cone volume
 and users satisfaction.
Conization is the method of choice in therapy for cervical dysplasia. Beside the risk of
 preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection
 margin is high.

 The Goldstandard standard technique in conization for women with cervical dysplasia is the
 large loop excision of the transformation zone ("LLETZ"). Nevertheless other techniques such
 as the excision of the abnormal tissue with the so called "Fischer Cone Biopsy Excisor" could
 provide advantages and is yet not enough investigated. The loop excision technique uses a
 circular electrode, in contrast Fischer Cone Biopsy Excision is done by a triangular
 electrode.

 It is unknown, whether the use of the circular or the triangular electrode is superior
 regarding the dysplasia-free resection margin rate and other outcome parameters such as the
 resected cone volume, postoperative bleeding and postoperative pain. Therefore, the
 investigator designed a randomized clinical trial of 160 women undergoing conization for
 cervical dysplasia, comparing the two electrosurgical techniques, "LLETZ-conization" and
 "Fischer Cone Biopsy Excision". The primary outcome of the study is the dysplasia-free
 resection margin rate independently proved by a pathologist, secondary outcomes are
 intraoperative blood loss measured as difference in serum hemoglobin pre- and
 postoperatively, postoperative pain according to a 11 step VAS scale, time to complete
 hemostasis measured in seconds, duration of the intervention measured in minutes, resected
 cone volume, users satisfaction according to a 11 step VAS scale and intra- and postoperative
 complications, defined as necessity to intervene surgically up to 14 days postoperatively.

 The study Population consists of women undergoing conization for histologically proven
 cervical dysplasia.
Inclusion Criteria:

 -  histologically proven cervical dysplasia

 -  colposcopy Prior to conization

 -  informed consent

 -  no known hematologic disorder

 Exclusion Criteria:

 -  significant language barrier

 -  a personal history of conization

 -  pregnancy

 -  the use of blood thinner

 -  unwillingness to participate