NCT01806012

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 the use of the Enseal sealing instrument for supracervical hysterectomy leads to a shortening of the operation time.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
Last Updated

March 6, 2013

Status Verified

March 1, 2013

Enrollment Period

1 year

First QC Date

February 19, 2013

Last Update Submit

March 5, 2013

Conditions

Indications for Laparoscopic Supracervical Hysterectomy

Keywords

Supracervical HysterectomyLeiomyomasAdenomyosis

Outcome Measures

Primary Outcomes (1)

  • Operation time

    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 Outcomes (2)

  • Blood loss

    Day 2

  • Post-operative pain

    Day 2

Study Arms (2)

Enseal

EXPERIMENTAL

Tissue sealing with Enseal device

Device: Sealing tissue with the Enseal device

Supracervical hysterectomy using conventional instruments

ACTIVE COMPARATOR

Supracervical hysterectomy using conventional instruments

Procedure: Conventional supracervical hysterectomy

Interventions

Sealing tissue with the Enseal deviceDEVICE
Enseal
Conventional supracervical hysterectomyPROCEDURE
Supracervical hysterectomy using conventional instruments

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Women' Clinic Tübingen

Tübingen, 72076, Germany

Location

Related Publications (2)

  • Rothmund R, Kraemer B, Brucker S, Taran FA, Wallwiener M, Zubke A, Wallwiener D, Zubke W. Laparoscopic supracervical hysterectomy using EnSeal vs standard bipolar coagulation technique: randomized controlled trial. J Minim Invasive Gynecol. 2013 Sep-Oct;20(5):661-6. doi: 10.1016/j.jmig.2013.04.014. Epub 2013 Jun 20.

    PMID: 23791399DERIVED

  • Rothmund R, Szyrach M, Reda A, Enderle MD, Neugebauer A, Taran FA, Brucker S, Hausch A, Wallwiener C, Kraemer B. A prospective, randomized clinical comparison between UltraCision and the novel sealing and cutting device BiCision in patients with laparoscopic supracervical hysterectomy. Surg Endosc. 2013 Oct;27(10):3852-9. doi: 10.1007/s00464-013-2994-4. Epub 2013 May 14.

    PMID: 23670744DERIVED

MeSH Terms

Conditions

LeiomyomaAdenomyosis

Condition Hierarchy (Ancestors)

Neoplasms, Muscle TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2013

First Posted

March 6, 2013

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

March 6, 2013

Record last verified: 2013-03

Locations

DE(1)