Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern (LSH-LAPCONE)
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|ClinicalTrials.gov Identifier: NCT00921778|
Recruitment Status : Unknown
Verified August 2008 by Ullevaal University Hospital.
Recruitment status was: Recruiting
First Posted : June 16, 2009
Last Update Posted : June 16, 2009
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).
|Condition or disease||Intervention/treatment||Phase|
|Vaginal Bleeding||Device: Lapcone Procedure: laparoscopic supracervical hysterectomy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||140 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||December 2010|
|Estimated Study Completion Date :||December 2011|
- Device: Lapcone
Use of Lapcone during LSH
- Procedure: laparoscopic supracervical hysterectomy
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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00921778
|Contact: Espen Berner, MD||+47 firstname.lastname@example.org|
|Contact: Marit Lieng, MD||+ 47 email@example.com|
|Ullevaal University Hospital||Recruiting|
|Contact: Espen Berner, MD +47 48007701 firstname.lastname@example.org|
|Contact: Marit Lieng, MD +47 98606578 email@example.com|
|Principal Investigator: Espen Berner, MD|