Our 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.
ID
Bron
Verkorte titel
Aandoening
vaginal hysterectomy, vessel sealing, ligasure, pelvic floor function
vaginale uterus extirpatie, bekkenbodemfunctie
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Post operative pain as measured on the visual analoge score.
Achtergrond van het onderzoek
Randomized 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.
Doel van het onderzoek
Our 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.
Onderzoeksopzet
Questionairre before operation, six weeks and six months after operation and a daily questionairre during hospitalisation till two weeks after operation.
Onderzoeksproduct en/of interventie
Vaginal hysterectomy with the help of Ligasure device versus vaginal hysterectomy according to the conventional technique.
Publiek
Academic Medical Center
Amsterdam
The Netherlands
+31 (0)6 30172563
m.m.lakeman@amc.uva.nl
Wetenschappelijk
Academic Medical Center
Amsterdam
The Netherlands
+31 (0)6 30172563
m.m.lakeman@amc.uva.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Candidate for vaginal hysterectomy for benign disease;
2. Age above 18 years.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Vaginal hysterectomy for prolapse;
2. Complaints.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL1694 |
| NTR-old | NTR1795 |
| Ander register | MEC AMC : 09/006 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd |