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:


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
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: 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:
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 July 31, 2014