Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy

March 5, 2013 updated by: Bernhard Kraemer, University Hospital Tuebingen

Use of the Enseal Intrument for Laparoscopic Supracervical Hysterectomy: a Randomized, Single-Blinded Study Comparing the Efficacy to the Routine Procedure

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University Women' Clinic Tübingen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Enseal
Tissue sealing with Enseal device
Device: Sealing tissue with the Enseal device
ACTIVE_COMPARATOR: Supracervical hysterectomy using conventional instruments
Procedure: Conventional supracervical hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 2
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.
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Collaborators

Ethicon Endo-Surgery (Europe) GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2010

Primary Completion (ACTUAL)

August 1, 2011

Study Completion (ACTUAL)

August 1, 2011

Study Registration Dates

First Submitted

February 19, 2013

First Submitted That Met QC Criteria

March 5, 2013

First Posted (ESTIMATE)

March 6, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 05022013

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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