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

Vaginal Bleeding Clinical Trial

— LSH-LAPCONE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00921778
• Other study ID #: LSH-LAPCONE UUS
• Status: Recruiting
• Phase: N/A
• First received: June 15, 2009
• Last updated: June 15, 2009
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: August 2008
• Source: Ullevaal University Hospital
• Contact: Espen Berner, MD
• Phone: +47 48007701
• Email: espen.berner[@]uus.no
• Is FDA regulated: No
• Health authority: Norway: Regional komitè for medisinsk forskningsetikk (REK)
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Uterine Hemorrhage
• Vaginal Bleeding

Intervention

Device:
• Lapcone
Use of Lapcone during LSH

Procedure:
• laparoscopic supracervical hysterectomy
laparoscopic supracervical hysterectomy

Locations

Country	Name	City	State
Norway	Ullevaal University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Ullevaal University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of vaginal bleeding 12 months after the procedure.		12 months after operation	No
Secondary	Patient satisfaction 12 months after the procedure (10-point analogue scale).		12 months after operation	No

External Links

•   homepage Ullevaal University Hospital