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

Study Overview
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Brief Summary
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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).

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

Conditions
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Vaginal Bleeding

Intervention / Treatment
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* Device: Lapcone
* Procedure: laparoscopic supracervical hysterectomy


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Lapcone|Use of Lapcone during LSH|
|Procedure: laparoscopic supracervical hysterectomy|laparoscopic supracervical hysterectomy|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of vaginal bleeding 12 months after the procedure. |  | 12 months after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction 12 months after the procedure (10-point analogue scale). |  | 12 months after operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic supracervical hysterectomy, Vaginal bleeding, Patient satisfaction, vaginal bleeding after laparoscopic hysterectomy