Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern (LSH-LAPCONE)
|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 ]
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|