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Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern (LSH-LAPCONE)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by Ullevaal University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ullevaal University Hospital
ClinicalTrials.gov Identifier:
NCT00921778
First received: June 15, 2009
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

The occurrence of persistent vaginal bleeding following laparoscopic supracervical hysterectomy (LSH) is reported in the wide range of 0 % - 25 %. Experienced gynaecologists have claimed that removal of any remaining endometrium in a reverse cone pattern at the time of the hysterectomy reduces the occurrence of persistent vaginal bleeding to a minimum. The effect of this particular technique has not been reported.

Ullevaal University Hospital have developed an unipolar electrode for this study (Lapcone electrode, mod. UUS, L: 25cm, 6x10, Art. No. REM-270, Ross Electro Medical Ltd, Unit K1&K2, Quarry Fields Estate, Mere, Wiltshire BA12 6LA, London, UK). The electrode is CE approved.

Outcome: 1.Occurrence of vaginal bleeding 12 months after the procedure. 2. Patient satisfaction 12 months after the procedure (10-point analogue scale).

Design: Prospective randomised trial. Methods; The study participants are randomised to laparoscopic supracervical hysterectomy performed by perioperative electrocoagulation from the upper cervical canal (n=70) or performed by excision of the endocervix in a reverse cone pattern followed by electrocoagulation of the upper cervical canal (n =70).


Condition Intervention
Vaginal Bleeding
 Device: Lapcone
Procedure: laparoscopic supracervical hysterectomy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern

Resource links provided by NLM:

MedlinePlus related topics: Hysterectomy
U.S. FDA Resources

Further study details as provided by Ullevaal University Hospital:

Primary Outcome Measures:
  • Occurrence of vaginal bleeding 12 months after the procedure. [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient satisfaction 12 months after the procedure (10-point analogue scale). [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]

Estimated Enrollment: 140
Study Start Date: September 2008
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Lapcone
    Use of Lapcone during LSH
    Procedure: laparoscopic supracervical hysterectomy
    laparoscopic supracervical hysterectomy
  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All premenopausal women who are referred to the departement due to a benign condition requiring hysterectomy and who have given informed consent are eligible for study recruitment

Exclusion Criteria:

  • Women who are unable to communicate in written Norwegian or oral English language.
  • Woman with a previous history of cervical dysplasia, with cellular changes suggestive of dysplasia in preoperative smear or wtih atypical hyperplasia og malignancy in preoperative endometrial biopsy
  • Women who after a thorough clinical evaluation are found to be more suited for vaginal, abdominal or total hysterectomy
  • Women with a coexisting condition requiring no remaining ovaries after the procedure
  • Postmenopausal women
  • Women using hormone therapy (HT)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00921778

Contacts
Contact: Espen Berner, MD +47 48007701 espen.berner@uus.no
Contact: Marit Lieng, MD + 47 98606578 marit.lieng@uus.no

Locations
Norway
Ullevaal University Hospital Recruiting
Oslo, Norway
Contact: Espen Berner, MD     +47 48007701     espen.berner@uus.no    
Contact: Marit Lieng, MD     +47 98606578     marit.lieng@uus.no    
Principal Investigator: Espen Berner, MD            
Sponsors and Collaborators
Ullevaal University Hospital
  More Information

Additional Information:
homepage Ullevaal University Hospital  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ullevaal University Hospital, Oslo University Hostpital
ClinicalTrials.gov Identifier: NCT00921778     History of Changes
Other Study ID Numbers: LSH-LAPCONE UUS
Study First Received: June 15, 2009
Last Updated: June 15, 2009
Health Authority: Norway: Regional komitè for medisinsk forskningsetikk (REK)

Keywords provided by Ullevaal University Hospital:
Laparoscopic supracervical hysterectomy
Vaginal bleeding
Patient satisfaction
vaginal bleeding after laparoscopic hysterectomy

Additional relevant MeSH terms:
Hemorrhage
Uterine Hemorrhage
Pathologic Processes
Uterine Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013