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

University Hospital Tuebingen

Status

Completed

Conditions

Uterine Bleeding Disorders

Benign Uterine Conditions

Focus: Comparison of Two Instruments

Treatments

Device: BiCision®

Device: Ultracision® Har-monic Scalpel(Ethicon)

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01752725

04122012

Details and patient eligibility

About

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).

Enrollment

30 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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