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

June 15, 2009
June 15, 2009
September 2008
December 2010   (final data collection date for primary outcome measure)
Occurrence of vaginal bleeding 12 months after the procedure. [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
Patient satisfaction 12 months after the procedure (10-point analogue scale). [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern

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).

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Vaginal Bleeding
  • Device: Lapcone
    Use of Lapcone during LSH
  • Procedure: laparoscopic supracervical hysterectomy
    laparoscopic supracervical hysterectomy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
140
December 2011
December 2010   (final data collection date for primary outcome measure)

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)
Female
Not Provided
Yes
Contact: Espen Berner, MD +47 48007701 espen.berner@uus.no
Contact: Marit Lieng, MD + 47 98606578 marit.lieng@uus.no
Norway
 
NCT00921778
LSH-LAPCONE UUS
No
Ullevaal University Hospital, Oslo University Hostpital
Ullevaal University Hospital
Not Provided
Not Provided
Ullevaal University Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP