Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH)

Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.

The aim of the study is the evaluation of the efficiency and safety of the new, CE-certified thermofu-sion and dissection instrument BiCision® in comparison with the long established Ultracision® Har-monic Scalpel(Ethicon)during a laparoscopic supracervical hysterectomy (LASH).

Inclusion Criteria:

• age > 18
• gender: female
• indication for laparoscopic supracervical hysterectomy with no adnexectomyor other surgery
• will and the capability to comply the study requirements
• signed informed consent

Exclusion Criteria:

• Invasive malignome in the pelvis
• Cardiac pacemaker or implanted defibrilator if no informations are available about the compatibil-ity with RF energy
• Abnormal blood parameters (values less than factor 0.8 or more than 1.25 compared to the val-ues of creatinine and standard hemogram)
• Abnormal coagulation parameters: PTT > 40 sec. and / or Quick's-Value< 50% (the use of antiplateletsup to a max. of 100mg/d is no exclusion criteria)
• Inability to understand the purpose of the study
• status after a laparotomy by a longitudinal incision
• intraabdominal adhesions (at the beginning of the surgery ≥ 5 sectioning for adhesiolysis)
• open laparoscopy required
• different anatomical situations that yields to different surgery requirements
• conspicuous PAP, cervixmyoma or endometriosis of the rectovaginale space