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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01752725
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : December 19, 2012
ERBE Elektromedizin GmbH
Information provided by (Responsible Party):
Bernhard Kraemer, University Hospital Tuebingen

Brief Summary:
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).

Condition or disease Intervention/treatment
Uterine Bleeding Disorders Benign Uterine Conditions Focus: Comparison of Two Instruments Device: BiCision® Device: Ultracision® Har-monic Scalpel(Ethicon)

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.
Study Start Date : October 2011
Primary Completion Date : April 2012
Study Completion Date : April 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Arm Intervention/treatment
Experimental: BiCision Arm
Coagulation with BiCision
Device: BiCision®
Active Comparator: Ultracision Arm
Coagulation with Ultracision
Device: Ultracision® Har-monic Scalpel(Ethicon)

Primary Outcome Measures :
  1. Operation time [ Time Frame: Participants will be followed for the duration of hospital stay, an expexted average of 8 months ]
    The primary objective is the operation time for each preparation side and instrument needed from the beginning of the removal of the cornual structure of the uterus (uterine cornu) till the completely removal of the parametric tissue directly before removal of the corpus uteri from the cervix.

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01752725

University Hospital
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
ERBE Elektromedizin GmbH
Study Chair: Diethelm Wallwiener, Professor University Hospital Tuebingen
Principal Investigator: Bernhard Krämer, MD University Hospital Tuebingen

Responsible Party: Bernhard Kraemer, Executive / Investigator, University Hospital Tuebingen Identifier: NCT01752725     History of Changes
Other Study ID Numbers: 04122012
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: December 19, 2012
Last Verified: December 2012

Keywords provided by Bernhard Kraemer, University Hospital Tuebingen:
supracervical hysterectomy
vessel sealing
bipolar electrocoagulation

Additional relevant MeSH terms:
Blood Coagulation Disorders
Hemostatic Disorders
Uterine Hemorrhage
Hematologic Diseases
Vascular Diseases
Cardiovascular Diseases
Hemorrhagic Disorders
Uterine Diseases
Genital Diseases, Female
Pathologic Processes