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

December 14, 2012 updated by: Bernhard Kraemer, University Hospital Tuebingen

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BiCision Arm
Coagulation with BiCision
Device: BiCision®
ACTIVE_COMPARATOR: Ultracision Arm
Coagulation with Ultracision
Device: Ultracision® Har-monic Scalpel(Ethicon)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Participants will be followed for the duration of hospital stay, an expexted average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Erbe Elektromedizin GmbH

Investigators

  • Study Chair: Diethelm Wallwiener, Professor, University Hospital Tuebingen
  • Principal Investigator: Bernhard Krämer, MD, University Hospital Tuebingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

April 1, 2012

Study Completion (ACTUAL)

April 1, 2012

Study Registration Dates

First Submitted

December 4, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (ESTIMATE)

December 19, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 14, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 04122012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Bleeding Disorders

Clinical Trials on BiCision®

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Sri Lanka

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe