Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern (LSH-LAPCONE)
Recruitment status was Recruiting
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 15, 2009 | ||||||||
| Last Updated Date | June 15, 2009 | ||||||||
| Start Date ICMJE | September 2008 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Occurrence of vaginal bleeding 12 months after the procedure. [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | No Changes Posted | ||||||||
| Current Secondary Outcome Measures ICMJE |
Patient satisfaction 12 months after the procedure (10-point analogue scale). [ Time Frame: 12 months after operation ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern | ||||||||
| Official Title ICMJE | Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern | ||||||||
| Brief Summary | 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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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
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| Condition ICMJE | Vaginal Bleeding | ||||||||
| Intervention ICMJE |
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| Study Arm (s) | Not Provided | ||||||||
| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 140 | ||||||||
| Estimated Completion Date | December 2011 | ||||||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | Not Provided | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Norway | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00921778 | ||||||||
| Other Study ID Numbers ICMJE | LSH-LAPCONE UUS | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ullevaal University Hospital, Oslo University Hostpital | ||||||||
| Study Sponsor ICMJE | Ullevaal University Hospital | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Ullevaal University Hospital | ||||||||
| Verification Date | August 2008 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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