Status:
COMPLETED
Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy
Lead Sponsor:
University Hospital Tuebingen
Collaborating Sponsors:
Ethicon Endo-Surgery (Europe) GmbH
Conditions:
Indications for Laparoscopic Supracervical Hysterectomy
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2011
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01806012
Start Date
August 1 2010
End Date
August 1 2011
Last Update
March 6 2013
Active Locations (1)
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1
University Women' Clinic Tübingen
Tübingen, Germany, 72076