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

Not Applicable

• Conditions: Vaginal Bleeding

• Registration Number: NCT00921778
• Lead Sponsor: Ullevaal University Hospital

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-08
• Study Start: 2008-09
• Study First Submitted: 2009-06-15
• Study First Submitted QC: 2009-06-15
• Last Update Submitted: 2009-06-15
• Study First Posted: 2009-06-16
• Last Update Posted: 2009-06-16
• Primary Completion: 2010-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 140

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Occurrence of vaginal bleeding 12 months after the procedure.	12 months after operation

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction 12 months after the procedure (10-point analogue scale).	12 months after operation

Trial Locations

Locations (1)

Ullevaal University Hospital; 🇳🇴 Oslo, Norway