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)


The Impact of Decision Aids in Gallbladder and Inguinal Hernia Surgery


- candidate number29599
- NTR NumberNTR7501
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-sep-2018
- Secondary IDs2017-3972 Commissie Mensgebonden Onderzoek
- Public TitleThe Impact of Decision Aids in Gallbladder and Inguinal Hernia Surgery
- Scientific TitleThe Impact of Decision Aids in Gallbladder and Inguinal Hernia Surgery on Treatment Preferences and Patient Reported Outcomes; a Prospective Study
- ACRONYM
- hypothesis
- Healt Condition(s) or Problem(s) studiedShared decision making, Hernia inguinal, Surgery, Treatment, gall stones
- Inclusion criteria- 18 years of age or older
- refered for surgical consultation with gallstones or inguinal hernia
- Exclusion criteria- Complicated gallstone disease
- Mentally incompetent
- Insufficient knowledge of Dutch language
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeobservational
- planned startdate 8-okt-2018
- planned closingdate31-dec-2019
- Target number of participants350
- InterventionsDecision Aids:
Tools with balanced, patient adjusted information about the harms and benefits of treatments. Decision aids facilitate SDM.

Questionnaires:
EQ5D
Gallstone Symptom List (GSL) Or EuraHS
Shared Decision Making Questionnaire - 9 (SDM-9)
Satisfaction, Pain, Treatment preference
- Primary outcomeThe main study endpoint will be the change in patients treatment preference before and after the decision aid.
- Secondary outcome- The difference between treatment preference of physician and patient after the decision aid.
- The difference between physicians and patients treatment preferences and final shared decision.
- Patient satisfaction after 6 months.
- Patient Reported Outcomes after 6 months.
- Operation rate
- Timepointst = 0 months

Decision Aid

Questionnaires:
Patient demographics
EQ5D
GSL / EuraHS
SDM-9
Treatment Preference

t = 3 months

Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore

t = 6 months

Questionnaires:
EQ5D
GSL / EuraHS
SDM-9
Satisfaction and Painscore
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIES Carmen Latenstein
- CONTACT for SCIENTIFIC QUERIES Carmen Latenstein
- Sponsor/Initiator Radboud University Medical Center Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Radboud University Medical Center Nijmegen
- Publications
- Brief summaryThis study is a single centre, prospective cohort study. In this single centre decision aids, tools with balanced, patient adjusted information about the harms and benefits of treatments (surgery or no surgery), are standardized care for patients with gallstones and inguinal hernia. Patients will all be recruited in the Netherlands.
We aim to determine the change in patient treatment preference before and after the decision aid. Secondarily, we research patient reported outcomes with questionnaires after 3 and 6 months.
After inclusion of 350 patients and 6 months follow-up, statistical analysis will be carried out using IBM SPSS.
- Main changes (audit trail)
- RECORD27-sep-2018 - 7-okt-2018


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