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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).
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lapcone | Device | Use of Lapcone during LSH | ||
| laparoscopic supracervical hysterectomy | Procedure | laparoscopic supracervical hysterectomy |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of vaginal bleeding 12 months after the procedure. | 12 months after operation |
| Measure | Description | Time Frame |
|---|---|---|
| Patient satisfaction 12 months after the procedure (10-point analogue scale). | 12 months after operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Espen Berner, MD | Contact | +47 48007701 | espen.berner@uus.no | |
| Marit Lieng, MD | Contact | + 47 98606578 | marit.lieng@uus.no |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ullevaal University Hospital | Recruiting | Oslo | Norway |
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| Label | URL |
|---|---|
| homepage Ullevaal University Hospital | View source |
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| ID | Term |
|---|---|
| D014592 | Uterine Hemorrhage |
| D017060 | Patient Satisfaction |
| ID | Term |
|---|---|
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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