search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Pelvic physiotherapy after surgical treatment for cervical cancer


- candidate number2860
- NTR NumberNTR1114
- ISRCTNISRCTN wordt niet meer aangevraagd
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR5-nov-2007
- Secondary IDsMEC07/123 MEC AMC
- Public TitlePelvic physiotherapy after surgical treatment for cervical cancer
- Scientific TitleA randomized controlled trial to evaluate the effect on pelvic floor function of pelvic physiotherapy following radical hysterectomy in early stage cervical cancer.
- ACRONYMPelvic physiotherapy after surgical treatment for cervical cancer
- hypothesisPatients who received pelvic physiotherapy have a better quality of life related to miction, defecation and sexual problems and less problems with micturition defecation and sexual problems occur in this group.
- Healt Condition(s) or Problem(s) studiedCervix cancer
- Inclusion criteria1. Cervical cancer FIGO stage IB-IIA;
2. To undergo radical hysterectomy;
3. Above 18 years of age;
4. Physically able to perform pelvic training;
5. Sufficient knowledge of Dutch language.
- Exclusion criteriaMedical history of bowel- and/or bladder surgery.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2007
- planned closingdate1-sep-2010
- Target number of participants72
- InterventionsPelvic physiotherapy.
- Primary outcomeQuality of life related to micturition, defecation and sexuality.
- Secondary outcome1. General quality of life;
2. Bladder function;
3. Provided hours of physiotherapy additional to the standard intervention;
4. Health care consumption because of pelvic floor symptoms in the first year after radical hysterectomy.
- Timepoints01-Sep-2007 start inclusion;
01-Sep-2009 end of inclusion;
01-Sep-2010 end of receiving questionnaires.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES M.H. Hazewinkel
- CONTACT for SCIENTIFIC QUERIES M.H. Hazewinkel
- Sponsor/Initiator Academic Medical Center (AMC)Department of Gynaecology
- Funding
(Source(s) of Monetary or Material Support)
Academic Medical Center (AMC), Department of Gynaecology
- PublicationsN/A
- Brief summaryPatients who undergo radical hysterectomy because of cervical cancer frequently experience (de novo) micturition and defecation symptoms after surgery. These symptoms are thought to mainly result from damage to autonomic nerve innervation during surgery. In the literature it has been stated that pelvic physiotherapy is effective in the management of pelvic floor symptoms, although this has not been proven to be true in patients treated for cervical cancer. The goal of our study is to find out whether pelvic physiotherapy gives a better pelvic floor related quality of life. This is evaluated with validated questionnaires. We also evaluate the bladder function with voiding diaries, uroflowmetry and measurement of the post-voiding residual volume. A secondary outcome is the health care consumption for pelvic floor problems in the first year after a radical hysterectomy. The measurements take place before the operation, 6 weeks, 3 months and 12 months after the operation.
- Main changes (audit trail)
- RECORD5-nov-2007 - 25-mrt-2008


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl