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Electrosurgical bipolar vessel sealing using LigaSure versus conventional clamping and suturing for vaginal hysterectomy: a randomized controlled trial.


- candidate number5693
- NTR NumberNTR1795
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-mei-2009
- Secondary IDs09/006 MEC AMC
- Public TitleElectrosurgical bipolar vessel sealing using LigaSure versus conventional clamping and suturing for vaginal hysterectomy: a randomized controlled trial.
- Scientific TitleElectrosurgical bipolar vessel sealing using LigaSure versus conventional clamping and suturing for vaginal hysterectomy: a randomized controlled trial.
- ACRONYMLigasure
- hypothesisOur hypothesis is that operating with Ligasure reduces post-operative pain and time till return to normal daily activities. Also through less nerve damage pelvic floor function might be better after operation with ligasure.
- Healt Condition(s) or Problem(s) studiedVaginal hysterectomy, Pelvic floor function
- Inclusion criteria1. Candidate for vaginal hysterectomy for benign disease;
2. Age above 18 years.
- Exclusion criteria1. Vaginal hysterectomy for prolapse;
2. Complaints.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-apr-2009
- planned closingdate1-mei-2010
- Target number of participants100
- InterventionsVaginal hysterectomy with the help of Ligasure device versus vaginal hysterectomy according to the conventional technique.
- Primary outcomePost operative pain as measured on the visual analoge score.
- Secondary outcomeSurgery time, blood loss, hospital stay, limitations in daily functioning, pelvic floor function, generic quality of life and costs.
- TimepointsQuestionairre before operation, six weeks and six months after operation and a daily questionairre during hospitalisation till two weeks after operation.
- Trial web sitehttp://www.studies-obsgyn.nl/Ligasure/page.asp?page_id=745
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.M.E. Lakeman
- CONTACT for SCIENTIFIC QUERIES M.M.E. Lakeman
- Sponsor/Initiator Academic Medical Center (AMC), Amsterdam
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC)
- PublicationsN/A
- Brief summaryRandomized controlled trial to study the effects of LigaSure vessel sealing versus conventional technique, in vaginal hysterectomy, on the operative parameters, post-operative pain, recovery and pelvic floor function.
- Main changes (audit trail)
- RECORD4-mei-2009 - 23-sep-2009


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