Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 November 27, 2014