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Optimizing perioperative care for gynaecological patients.


- candidate number9708
- NTR NumberNTR2933
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR10-jun-2011
- Secondary IDs171102015 ZonMW
- Public TitleOptimizing perioperative care for gynaecological patients.
- Scientific TitleThe cost-effectiveness of a transmural, perio-operative care program for gynecology.
- ACRONYM
- hypothesisCompared to usual care, a new perioperative care program will improved recovery and accelerated resumption of (work)activities. Resumption of work contributes significantly to QOL and will prevent disability due to general and mental health problems and associated financial deprivation. Moreover, the program will reduce direct and indirect costs for the Dutch society.
- Healt Condition(s) or Problem(s) studiedHysterectomy, Laparoscopic adnex surgery
- Inclusion criteria1. Female;
2. Age between 18-65 years;
3. Employed (>8 hours/week);
4. Scheduled for a hysterectomy or laparoscopic adnexal surgery in one of the participating hospitals.
- Exclusion criteria1. Malignancy;
2. (Ectopic) pregnancy;
3. Deep infiltrating endometriosis;
4. Concomitant surgical procedures or major health problems affecting daily activities;
5. Sick listed for more than 6 months;
6. Dealing with a lawsuit to their employer;
7. Not able to understand or complete the questionnaires;
8. No Internet access.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate31-dec-2013
- Target number of participants280
- InterventionsControl group: Usual care.

Intervention group: Multidisciplinary peri-operative care program including an interactive weblog and additional workplace intervention in case of delayed recovery. The interactive weblog provides patient-tailored detailed instructions on the resumption of (work)activities. These recommendations are based on consensus achieved among gynaecologists, GPs, OPs and GPs using a structural consensus method, including a systematic review. The weblog additionally provides tools to improve self-empowerment and to improve the communication between patients, care-providers and employers, preventing conflicting recommendations. Patients' recovery can be closely monitored by the weblog, allowing the application of a very successful workplace (participative ergonomy) intervention to improve patientsí recovery and reduce sick-leave.
- Primary outcome1. Return to work (RTW);
2. Recovery Specific Quality of Life (RS-QoL).
- Secondary outcome1. Cost-effectiveness;
2. Patient satisfaction.
- Timepoints1. Baseline;
2. 2 weeks;
3. 6 weeks;
4. 12 weeks;
5. 6 months;
6. 12 months.
- Trial web sitewww.ikherstel.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIESMD. E.V.A. Bouwsma
- CONTACT for SCIENTIFIC QUERIESMD. PhD. J.A.F. Huirne
- Sponsor/Initiator VU University Medical Center, EMGO+ Institute
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryResumption of work activities after gynaecological surgeries takes much longer than expected, irrespective of surgical technique and level of invasiveness. Considering the high costs of sick leave and the adverse consequences of sick leave for employees in combination with the high number of gynaecological procedures performed annually in the Netherlands, prolonged sickleave induce unnecessary high costs for the society. In this study we will study the (cost)effectiveness of a transmural, perioperative care program for gynaecological patients.
- Main changes (audit trail)
- RECORD10-jun-2011 - 24-jun-2011


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