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Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01806012
First Posted: March 6, 2013
Last Update Posted: March 6, 2013
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.
Collaborator:
Ethicon Endo-Surgery (Europe) GmbH
Information provided by (Responsible Party):
Bernhard Kraemer, University Hospital Tuebingen
  Purpose
The use of the EnSeal® instrument for laparoscopic supracervical hysterectomy in a randomized, single-blinded comparison to the conventional procedure. The objective of the study is to investigate if the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.

Condition Intervention
Indications for Laparoscopic Supracervical Hysterectomy Device: Sealing tissue with the Enseal device Procedure: Conventional supracervical hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure

Resource links provided by NLM:


Further study details as provided by Bernhard Kraemer, University Hospital Tuebingen:

Primary Outcome Measures:
  • Operation time [ Time Frame: Day 1 ]
    The following times were documented: total operation time; T1 = start of the operation until cornual structures were ready to be dissected; T2 = the time from the first coagulation and cutting of the cornual structures until the complete preparation of each parametrial side directly before cervical detachment; T3 = time needed for the cervical detachment and subsequent steps (morcellation, closure of trocar sites) until the end of the surgical procedure.


Secondary Outcome Measures:
  • Blood loss [ Time Frame: Day 2 ]
    The perioperative blood loss (ΔHb) was calculated using the comparison of the preoperative red blood cells (RBC) versus the RBC on the first post-operative day. The intraoperative blood loss was measured by the suction unit (categories: < 50 ml, 50 - 100 ml, > 100 ml) and by the number of applied blood transfusions.

  • Post-operative pain [ Time Frame: Day 2 ]
    Post-operative pain was documented according to a visual analog pain scale from 1 (no pain) to 10 (maximum pain) during hospital stay.


Enrollment: 160
Study Start Date: August 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Enseal
Tissue sealing with Enseal device
Device: Sealing tissue with the Enseal device
Active Comparator: Supracervical hysterectomy using conventional instruments
Supracervical hysterectomy using conventional instruments
Procedure: Conventional supracervical hysterectomy

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Age >18 years
  • Indication for supracervical hysterectomy without additional surgical procedures (i. e. oophorectomy)
  • Willingness and capability to comply with all study tests, procedures, and assessment tools
  • Capability of providing informed consent.

Exclusion Criteria:

  • History of, or evidence of, gynecologic malignancy within the past five years
  • Pace maker, internal defibrilator/cardioconverter
  • Impaired coagulation parameters
  • Unwillingness to be randomized to treatment
  • History of median laparotomy
  • Intraabdominal adhesions
  • Requirement for open laparoscopy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01806012


Locations
Germany
University Women' Clinic Tübingen
Tübingen, Germany, 72076
Sponsors and Collaborators
University Hospital Tuebingen
Ethicon Endo-Surgery (Europe) GmbH
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bernhard Kraemer, Principal Investigator, University Hospital Tuebingen
ClinicalTrials.gov Identifier: NCT01806012     History of Changes
Other Study ID Numbers: 05022013
First Submitted: February 19, 2013
First Posted: March 6, 2013
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Bernhard Kraemer, University Hospital Tuebingen:
Supracervical Hysterectomy
Leiomyomas
Adenomyosis