Vaginal Bleeding Clinical Trial
Official title:
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
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).
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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