Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

This study has been completed.
Sponsor:
Collaborator:
Ethicon Endo-Surgery (Europe) GmbH
Information provided by (Responsible Party):
Bernhard Kraemer, University Hospital Tuebingen
ClinicalTrials.gov Identifier:
NCT01806012
First received: February 19, 2013
Last updated: March 5, 2013
Last verified: March 2013
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
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 University Hospital Tuebingen:

Primary Outcome Measures:
  • Operation time [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01806012

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

No publications provided by University Hospital Tuebingen

Additional 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
Study First Received: February 19, 2013
Last Updated: March 5, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Tuebingen:
Supracervical Hysterectomy
Leiomyomas
Adenomyosis

ClinicalTrials.gov processed this record on April 23, 2014