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

Ullevaal University Hospital

Status: Unknown

Conditions: Vaginal Bleeding

Treatments: Device: Lapcone; Procedure: laparoscopic supracervical hysterectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT00921778

LSH-LAPCONE UUS

Details and patient eligibility

About

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).

Enrollment: 140 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind