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

NCT ID: NCT00921778

Last Updated: 2009-06-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-12-31

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).

Conditions

Vaginal Bleeding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

Lapcone

Use of Lapcone during LSH

Intervention Type: DEVICE

laparoscopic supracervical hysterectomy

laparoscopic supracervical hysterectomy

Intervention Type: PROCEDURE

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)

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ullevaal University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Oslo University Hostpital

Locations

Ullevaal University Hospital

Oslo, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Espen Berner, MD

Role: CONTACT

espen.berner@uus.no

+47 48007701

Marit Lieng, MD

Role: CONTACT

marit.lieng@uus.no

+ 47 98606578

Facility Contacts

Espen Berner, MD

Role: primary

espen.berner@uus.no

+47 48007701

Marit Lieng, MD

Role: backup

marit.lieng@uus.no

+47 98606578

Related Links

http://www.ulleval.no

homepage Ullevaal University Hospital

Other Identifiers

LSH-LAPCONE UUS

Identifier Type: -

Identifier Source: org_study_id