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A tampon after vaginal surgery: useful or superfluous?


- candidate number1631
- NTR NumberNTR513
- ISRCTNincomplete data for ISRCTN
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR13-sep-2005
- Secondary IDsN/A 
- Public TitleA tampon after vaginal surgery: useful or superfluous?
- Scientific TitleA tampon after vaginal surgery: useful or superfluous?
- ACRONYMN/A
- hypothesis1. Is there, by using a vaginal tampon, less postoperative bleeding?;
2. Are there, by using a vaginal tampon, less postoperative infections?;
3. Is the result of prolapse surgery negatively influenced by not using a vaginal tampon?;
4. What kind of influence is there on the quality of life by using or not using a vaginal tampon?
- Healt Condition(s) or Problem(s) studiedVaginal surgery
- Inclusion criteriaAll vaginal surgery, willing to cooperate.
- Exclusion criteriaTVT/TOT surgery, combined abdominal-vaginal surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2005
- planned closingdate1-sep-2006
- Target number of participants150
- InterventionsThe use of a vaginal tampon in one group and no use of a vaginal tampon in the other group after vaginal surgery.
- Primary outcomeTo investigate whether there are less postoperative bleeding and hematomas after vaginal surgery by using a vaginal tampon.
- Secondary outcomeTo investigate the effect of the use of a tampon after vaginal surgery on the number and kind of postoperative infections, the effect on prolaps surgery and the effect on the quality of life.
- TimepointsN/A
- Trial web siteN/A
- statusinclusion stopped: follow-up
- CONTACT FOR PUBLIC QUERIES M.C. Vos
- CONTACT for SCIENTIFIC QUERIESDrs. M.E.M.H. Westerhuis
- Sponsor/Initiator
- Funding
(Source(s) of Monetary or Material Support)
- PublicationsN/A
- Brief summaryThe purpose of the trial is to investigate whether there is less postoperative bleeding by using a tampon after vaginal surgery, whether there are more complications like infections, whether the result of prolapse surgery is negatively influenced by not using a tampon and what kind of influence there is on the quality of life.
There will be a comparison of two randomised groups, one group will receive a vaginal tampon and the other group won't. All women who will be submitted to vaginal surgery, will be asked to cooperate.
- Main changes (audit trail)
- RECORD13-sep-2005 - 2-dec-2008


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