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Substitution of usual perioperative care by e-health & ICT


- candidate number18585
- NTR NumberNTR4699
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR18-jul-2014
- Secondary IDs837002409 ZonMW
- Public TitleSubstitution of usual perioperative care by e-health & ICT
- Scientific TitleSUBSTITUTION OF USUAL PERIOPERATIVE CARE BY E-HEALTH & ICT; a cost-effectiveness analysis
- ACRONYMIkherstel3.0
- hypothesisConsiderable health efficiency gains can be achieved by the substitution and optimization of usual perioperative care by means of e-health and ICT.
- Healt Condition(s) or Problem(s) studiedPerioperative care, E-health, Adnexal surgery, Cholecystectomy, Hernia inguinal, Hernia repair surgery
- Inclusion criteriaAll patients aged from 18 to 70 years old who are on the waiting list for a laparoscopic cholecystectomy, an open or laparoscopic colectomy, an open or laparoscopic appendectomy, open or laparoscopic inguinal hernia surgery, an abdominal or laparoscopic hysterectomy or laparoscopic adnexal surgery.
- Exclusion criteria- Surgery without a curative intention or with additional radio- or chemotherapy
- (Ectopic) pregnancy
- Deep infiltrating endometriosis
- Adnexal surgery because of pelvic inflammatory disease/ tubal ovarian abces
- Colectomy because of crohnís disease or ulcerative colitis
- Perforated appendicitis
- Combination of surgery with other surgical procedures
- Concomitant health problems affecting daily activities
- Severe comorbidity which might complicate the postoperative course
- Patient who are unable to understand the information belonging the research
- Insufficient understanding or ability to fill in (Dutch) questionnaires
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2015
- planned closingdate1-nov-2016
- Target number of participants307
- InterventionsMultidisciplinary peri-operative care program including an interactive webportal. It aims to improve recovery and reduce costs by:
-SELFMANAGEMENT & EMPOWERMENT of patients during the perioperative period by supporting them with personalized pre- and postoperative recommendations to return to normal (work) activities. These recommendations are tailor made: they are based on patientís own input of normal preoperative activities and the surgical technique applied (using algoritms).
-MONITORING OF POSTOPERATIVE CARE: With the webportal the patient as well as all involved physicians can monitor patientís recovery (bench mark information) and thus identify recovery problems.
-E-CONSULTATION is offered to patients to ask questions in case of recovery problems or to substitute standard postoperative consultation in outpatient clinics
- Primary outcome- Quality-of-life
- Return-to-normal activities including work (RNA/RTW)
- Secondary outcome- Return to physical activities
- Return to work
- Length of recovery
- Empowerment
- Pain intensity
- Timepoints1. Baseline;
2. 2 weeks;
3. 6 weeks;
4. 12 weeks;
5. 6 months;
- Trial web sitewww.ikherstel.nl
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES E. Meij, van der
- CONTACT for SCIENTIFIC QUERIESDr. Han J.R. Anema
- 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 summaryIn the last decade the number of surgeries increased with 30% in the Netherlands. The increase of surgeries leads to rising hospital care costs. To reduce costs, in-hospital perioperative care is increasingly reduced due to one day hospitalisations and transferred to primary care. Guidance & monitoring on recovery and resumption of (work)activities are mostly not provided in secondary and primary care. Studies showed that due to the poor quality of usual perioperative care, return-to-normal-activities/work after surgery is hampered, leading to high productivity loss costs. We hypothesize that considerable health efficiency gains can be achieved by the substitution and optimization of usual perioperative care by means of e-health and ICT. In this trial we will study the (cost)effectiveness of a transmural, perioperative care program for patients undergoing abdominal surgery.
- Main changes (audit trail)28-okt-2015:

Inclusion NEW:
All patients aged from 18 to 75 years old who are on the waiting list for an elective laparoscopic cholecystectomy, open or laparoscopic inguinal hernia surgery, or elective laparoscopic adnexal surgery.

Exclusion NEW:
- (suspicion of) malignancy
- Deep infiltrating endometriosis
- Adnexal surgery because of pelvic inflammatory disease/ tubal ovarian abces
- Combination of surgery with other surgical procedures
- Concomitant health problems affecting daily activities
- Severe comorbidity which might complicate the postoperative course
- Patient who are unable to understand the information belonging the research
- Insufficient understanding or ability to fill in (Dutch) questionnaires

Interventions NEW:
Multidisciplinary peri-operative care program including an interactive webportal. It aims to improve recovery and reduce costs by:
-SELFMANAGEMENT & EMPOWERMENT of patients during the perioperative period by supporting them with personalized pre- and postoperative recommendations to return to normal (work) activities. These recommendations are tailor made: they are based on patientís own input of normal preoperative activities and the surgical technique applied (using algoritms). An accelerometer will be used as an aid for patients to monitor and give feedback on recovery. Patients have to wear the accelerometer from the seventh day before surgery and a number weeks after surgery.
-MONITORING OF POSTOPERATIVE CARE: With the webportal the patient as well as all involved physicians can monitor patientís recovery (bench mark information) and thus identify recovery problems.
-E-CONSULTATION is offered to patients to ask questions in case of recovery problems or to substitute standard postoperative consultation in outpatient clinics

Primary Outcome NEW:
- Return-to-normal activities including

Secondary outcome NEW:
- Quality-of-life
- Return to physical activities
- Return to work
- Length of recovery
- Empowerment
- Pain intensity
- Patient satisfaction
- Costs

Timepoints NEW:
1. Baseline;
2. 1 week;
3. 3 weeks
3. 6 weeks;
4. 12 weeks;
5. 6 months;
- RECORD18-jul-2014 - 28-okt-2015


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