|- candidate number||9708|
|- NTR Number||NTR2933|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-jun-2011|
|- Secondary IDs||171102015 ZonMW|
|- Public Title||Optimizing perioperative care for gynaecological patients.|
|- Scientific Title||The cost-effectiveness of a transmural, perio-operative care program for gynecology.|
|- hypothesis||Compared 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) studied||Hysterectomy, Laparoscopic adnex surgery|
|- Inclusion criteria||1. 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
|- Exclusion criteria||1. 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 received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||31-dec-2013|
|- Target number of participants||280|
|- Interventions||Control 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 outcome||1. Return to work (RTW);|
2. Recovery Specific Quality of Life (RS-QoL).
|- Secondary outcome||1. Cost-effectiveness;|
2. Patient satisfaction.
|- Timepoints||1. Baseline;|
2. 2 weeks;
3. 6 weeks;
4. 12 weeks;
5. 6 months;
6. 12 months.
|- Trial web site||www.ikherstel.nl|
|- CONTACT FOR PUBLIC QUERIES||MD. E.V.A. Bouwsma|
|- CONTACT for SCIENTIFIC QUERIES||MD. PhD. J.A.F. Huirne|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Resumption 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)|
|- RECORD||10-jun-2011 - 24-jun-2011|