Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern (LSH-LAPCONE)
Primary Purpose
Vaginal Bleeding
Status
Unknown status
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lapcone
laparoscopic supracervical hysterectomy
Sponsored by
About this trial
This is an interventional treatment trial for Vaginal Bleeding focused on measuring Laparoscopic supracervical hysterectomy, Vaginal bleeding, Patient satisfaction, vaginal bleeding after laparoscopic hysterectomy
Eligibility 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)
Sites / Locations
- Ullevaal University HospitalRecruiting
Outcomes
Primary Outcome Measures
Occurrence of vaginal bleeding 12 months after the procedure.
Secondary Outcome Measures
Patient satisfaction 12 months after the procedure (10-point analogue scale).
Full Information
NCT ID
NCT00921778
First Posted
June 15, 2009
Last Updated
June 15, 2009
Sponsor
Ullevaal University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00921778
Brief Title
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
Acronym
LSH-LAPCONE
Official Title
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
September 2008 (undefined)
Primary Completion Date
December 2010 (Anticipated)
Study Completion Date
December 2011 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Ullevaal University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Bleeding
Keywords
Laparoscopic supracervical hysterectomy, Vaginal bleeding, Patient satisfaction, vaginal bleeding after laparoscopic hysterectomy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
140 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
Lapcone
Intervention Description
Use of Lapcone during LSH
Intervention Type
Procedure
Intervention Name(s)
laparoscopic supracervical hysterectomy
Intervention Description
laparoscopic supracervical hysterectomy
Primary Outcome Measure Information:
Title
Occurrence of vaginal bleeding 12 months after the procedure.
Time Frame
12 months after operation
Secondary Outcome Measure Information:
Title
Patient satisfaction 12 months after the procedure (10-point analogue scale).
Time Frame
12 months after operation
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Espen Berner, MD
Phone
+47 48007701
Email
espen.berner@uus.no
First Name & Middle Initial & Last Name or Official Title & Degree
Marit Lieng, MD
Phone
+ 47 98606578
Email
marit.lieng@uus.no
Facility Information:
Facility Name
Ullevaal University Hospital
City
Oslo
Country
Norway
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Espen Berner, MD
Phone
+47 48007701
Email
espen.berner@uus.no
First Name & Middle Initial & Last Name & Degree
Marit Lieng, MD
Phone
+47 98606578
Email
marit.lieng@uus.no
First Name & Middle Initial & Last Name & Degree
Espen Berner, MD
12. IPD Sharing Statement
Links:
URL
http://www.ulleval.no
Description
homepage Ullevaal University Hospital
Learn more about this trial
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
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