An interventional study of Lapcone and laparoscopic supracervical hysterectomy in Vaginal Bleeding, sponsored by Ullevaal University Hospital. Status unknown at 1 site in Norway. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2009-06-16.
Sponsored by Ullevaal University Hospital · Not applicable, Interventional, and Treatment
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).
159 studies on the registry are indexed under Uterine Hemorrhage; 20 are open to participants now.
This study's planned enrollment of 140 is above the median of 98 across 113 interventional studies indexed under Uterine Hemorrhage.
Browse Uterine Hemorrhage studies →Ullevaal University Hospital is the lead sponsor of 77 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Use of Lapcone during LSH
laparoscopic supracervical hysterectomy
Occurrence of vaginal bleeding 12 months after the procedure.
Time frame: 12 months after operation
Patient satisfaction 12 months after the procedure (10-point analogue scale).
Time frame: 12 months after operation
The record gives a start of Sep 2008, a primary completion of Dec 2010 and a completion of Dec 2011. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Aug 2008. You cannot join it, but the record below documents what was studied.
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Ullevaal University Hospital