| - candidate number | 6335 |
| - NTR Number | NTR2087 |
| - ISRCTN | ISRCTN wordt niet meer aangevraagd. |
| - Date ISRCTN created | |
| - date ISRCTN requested | |
| - Date Registered NTR | 19-aug-2009 |
| - Secondary IDs | 2009/218 WC 2008/102 |
| - Public Title | Optimizing transmural perioperative care after gynaecological surgery. |
| - Scientific Title | The applicability and effectivity of guiding and empowering patients using a multidisciplinary guideline and weblog for resumption of (work)activities after gynaecological surgery. |
| - ACRONYM | N/A |
| - hypothesis | New perioperative care program will improve return to (work)activities, quality of life and quality of recovery in patients undergoing gynaecological surgical procedures, compared to usual given care. |
| - Healt Condition(s) or Problem(s) studied | Ovariectomy, Hysterectomy, Laparoscopic adnex surgery |
| - Inclusion criteria | Employed women (>8hrs/wk), aged between 18-65 years, scheduled in one of the participating hospitals for a hysterectomy or laparoscopic adnexal surgery due to benign disorders. |
| - Exclusion criteria | 1. Malignancy; 2. (Ectopic) pregnancy; 3. Deep infiltrating endometriosis; 4. Concomitant surgical procedures or major health problems affecting recovery or daily activities; 5. Sick listed for more than 4 weeks (or more than 2 months when the operation is the reason of the absence of work); 6. Dealing with a lawsuit against their employer; 7. Not able to understand or complete the questionnaires; 8. No access to the internet. |
| - mec approval received | yes |
| - multicenter trial | yes |
| - randomised | yes |
| - masking/blinding | Single |
| - control | Placebo |
| - group | Parallel |
| - Type | 2 or more arms, randomized |
| - Studytype | intervention |
| - planned startdate | 1-dec-2009 |
| - planned closingdate | 31-jul-2010 |
| - Target number of participants | 144 |
| - Interventions | Interactive website. Control group: Usual care, i.e. no standardised, preoperative or postoperative information on return to work will be given to the patients. They will have the possibility to use the weblog, but it doesn't contain any new information besides a patient information leaflet. Intervention group: Patients will be given access to their own personal webbased file to see their tailor-made pre- and postoperative information on convalescence (eg. lifting, resumption of daily activities and return to work). If the patients give their consent, the information may be used to inform the general practitioner, occupational physician and employer. Patients will fill in an ICT log, which allows detection of physical-, mental- or work-related recovery problems. If necessary, the patient will be given advice concerning additional care (e.g. clinical occupational physician trained as care manager, ergonomic intervention). Furthermore, patients have the opportunity to place questions related to their operation on their weblog, which will be answered. Additional information concerning the operation and convalescence, as well as a forum, will be available on the weblog. |
| - Primary outcome | Sick leave duration until full return to work. |
| - Secondary outcome | 1. Quality of life (generic and recovery specific); 2. Patient satisfaction; 3. Intensity of pain; 4. Time to resumption of various activities; 5. Recurrence of absence. |
| - Timepoints | Baseline, 2, 6, 12 and 26 weeks after operation. |
| - Trial web site | www.ikherstel.nl |
| - status | planned |
| - CONTACT FOR PUBLIC QUERIES | MD. A. Vonk Noordegraaf |
| - CONTACT for SCIENTIFIC QUERIES | MD. A. Vonk Noordegraaf |
| - 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, VU University Medical Center |
| - Publications | N/A |
| - Brief summary | Patients will be guided and empowered by using a weblog with multidisciplinary recommendations for resumption of (work) activities after gynaecological surgery. |
| - Main changes (audit trail) | |
| - RECORD | 19-aug-2009 - 12-nov-2009 |
- Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl