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

Primary Purpose

Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
BiCision®
Ultracision® Har-monic Scalpel(Ethicon)
Sponsored by
University Hospital Tuebingen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uterine Bleeding Disorders focused on measuring supracervical hysterectomy, vessel sealing, bipolar electrocoagulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BiCision Arm

Ultracision Arm

Arm Description

Coagulation with BiCision

Coagulation with Ultracision

Outcomes

Primary Outcome Measures

Operation time
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.

Secondary Outcome Measures

Full Information

First Posted
December 4, 2012
Last Updated
December 14, 2012
Sponsor
University Hospital Tuebingen
Collaborators
Erbe Elektromedizin GmbH
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1. Study Identification

Unique Protocol Identification Number
NCT01752725
Brief Title
Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH)
Official Title
Comparison of BiCision® Versus UltraCision® During Laparoscopic Supracervical Hysterectomy (LASH): A Prospective, Controlled, Randomized, Non-inferiority in Vivo Human Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
April 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital Tuebingen
Collaborators
Erbe Elektromedizin GmbH

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Bleeding Disorders, Benign Uterine Conditions, Focus: Comparison of Two Instruments
Keywords
supracervical hysterectomy, vessel sealing, bipolar electrocoagulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BiCision Arm
Arm Type
Experimental
Arm Description
Coagulation with BiCision
Arm Title
Ultracision Arm
Arm Type
Active Comparator
Arm Description
Coagulation with Ultracision
Intervention Type
Device
Intervention Name(s)
BiCision®
Intervention Type
Device
Intervention Name(s)
Ultracision® Har-monic Scalpel(Ethicon)
Primary Outcome Measure Information:
Title
Operation time
Description
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.
Time Frame
Participants will be followed for the duration of hospital stay, an expexted average of 8 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Diethelm Wallwiener, Professor
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Bernhard Krämer, MD
Organizational Affiliation
University Hospital Tuebingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Tübingen
ZIP/Postal Code
72076
Country
Germany

12. IPD Sharing Statement

Learn more about this trial

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

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