title: Substitution of Usual Perioperative Care by eHealth to Enhance Postoperative Recovery in Patients Undergoing General Surgical or Gynecological Procedures: Study Protocol of a Randomized Controlled Trial.
abstract: BACKGROUND
  Due to the strong reduction in the length of hospital stays in the last decade, the period of in-hospital postoperative care is limited. After discharge from the hospital, guidance and monitoring on recovery and resumption of (work) activities are usually not provided. As a consequence, return to normal activities and work after surgery is hampered, leading to a lower quality of life and higher costs due to productivity loss and increased health care consumption.
  
  
  OBJECTIVE
  With this study we aim to evaluate whether an eHealth care program can improve perioperative health care in patients undergoing commonly applied abdominal surgical procedures, leading to accelerated recovery and to a reduction in costs in comparison to usual care.
  
  
  METHODS
  This is a multicenter randomized, single-blinded, controlled trial. At least 308 patients between 18 and 75 years old who are on the waiting list for a laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication will be included. Patients will be randomized to an intervention or control group. The intervention group will have access to an innovative, perioperative eHealth care program. This intervention program consists of a website, mobile phone app, and activity tracker. It aims to improve patient self-management and empowerment by providing guidance to patients in the weeks before and after surgery. The control group will receive usual care and will have access to a nonintervention (standard) website consisting of the digital information brochure about the surgical procedure being performed. Patients are asked to complete questionnaires at 5 moments during the first 6 months after surgery. The primary outcome measure is time to return to normal activities based on a patient-specific set of 8 activities selected from the Patient-Reported Outcomes Measurement Information System (PROMIS) physical functioning item bank version 1.2. Secondary outcomes include social participation, self-rated health, duration of return to work, physical activity, length of recovery, pain intensity, and patient satisfaction. In addition, an economic evaluation alongside this randomized controlled trial will be performed from the societal and health care perspective. All statistical analyses will be conducted according to the intention-to-treat principle.
  
  
  RESULTS
  The enrollment of patients started in September 2015. The follow-up period will be completed in February 2017. Data cleaning and analyses have not begun as of the time this article was submitted.
  
  
  CONCLUSIONS
  We hypothesize that patients receiving the intervention program will resume their normal activities sooner than patients in the control group and costs will be lower.
  
  
  BACKGROUND
  Netherlands Trial Registry NTC4699; http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=4699 (Archived by WebCite at http://www.webcitation.org/6mcCBZmwy).
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.|Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Eva
authors.identifier: http://orcid.org/0000-0002-4905-1867
authors.initials: E
authors.lastname: van der Meij
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.|Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Judith Af
authors.identifier: http://orcid.org/0000-0002-8248-2677
authors.initials: JA
authors.lastname: Huirne
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.|Department of Obstetrics and Gynaecology, VU University Medical Center, Amsterdam, Netherlands.|Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Lokatie Oost, Amsterdam, Netherlands.
authors.forename: Esther Va
authors.identifier: http://orcid.org/0000-0002-9010-6743
authors.initials: EV
authors.lastname: Bouwsma
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Health Sciences, Vrije Universiteit, Faculty of Earth and Life Sciences, Amsterdam, Netherlands.
authors.forename: Johanna M
authors.identifier: http://orcid.org/0000-0002-1606-8742
authors.initials: JM
authors.lastname: van Dongen
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Caroline B
authors.identifier: http://orcid.org/0000-0003-4570-2826
authors.initials: CB
authors.lastname: Terwee
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Epidemiology and Biostatistics, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Peter M
authors.identifier: http://orcid.org/0000-0002-0101-3968
authors.initials: PM
authors.lastname: van de Ven
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.|Department of Surgery, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Chantal M
authors.identifier: http://orcid.org/0000-0002-2228-517X
authors.initials: CM
authors.lastname: den Bakker
authors.affiliation: Department of Surgery, Flevo Ziekenhuis, Almere, Netherlands.
authors.forename: Suzan
authors.identifier: http://orcid.org/0000-0002-0887-7304
authors.initials: S
authors.lastname: van der Meij
authors.affiliation: Department of Obstetrics and Gynaecology, Flevo Ziekenhuis, Almere, Netherlands.
authors.forename: W Marchien
authors.identifier: http://orcid.org/0000-0001-7245-1714
authors.initials: WM
authors.lastname: van Baal
authors.affiliation: Department of Surgery, Maxima Medisch Centrum, Veldhoven, Netherlands.
authors.forename: Wouter Kg
authors.identifier: http://orcid.org/0000-0003-1159-1857
authors.initials: WK
authors.lastname: Leclercq
authors.affiliation: Department of Obstetrics and Gynaecology, Maxima Medisch Centrum, Veldhoven, Netherlands.
authors.forename: Peggy Maj
authors.identifier: http://orcid.org/0000-0002-1951-1076
authors.initials: PM
authors.lastname: Geomini
authors.affiliation: Department of Surgery, Meander Medisch Centrum, Amersfoort, Netherlands.
authors.forename: Esther Cj
authors.identifier: http://orcid.org/0000-0002-9447-8181
authors.initials: EC
authors.lastname: Consten
authors.affiliation: Department of Obstetrics and Gynaecology, Meander Medisch Centrum, Amersfoort, Netherlands.
authors.forename: Steven E
authors.identifier: http://orcid.org/0000-0002-4094-4941
authors.initials: SE
authors.lastname: Schraffordt Koops
authors.affiliation: Department of Obstetrics and Gynaecology, Onze Lieve Vrouwe Gasthuis, Lokatie Oost, Amsterdam, Netherlands.
authors.forename: Paul Jm
authors.identifier: http://orcid.org/0000-0001-5111-3951
authors.initials: PJ
authors.lastname: van Kesteren
authors.affiliation: Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands.
authors.forename: Hein Bac
authors.identifier: http://orcid.org/0000-0002-9787-8228
authors.initials: HB
authors.lastname: Stockmann
authors.affiliation: Department of Obstetrics and Gynaecology, Spaarne Gasthuis, Haarlem, Netherlands.
authors.forename: A Dorien
authors.identifier: http://orcid.org/0000-0002-7504-4468
authors.initials: AD
authors.lastname: Ten Cate
authors.affiliation: Department of Surgery, Diakonessenhuis, Utrecht, Netherlands.
authors.forename: Paul Hp
authors.identifier: http://orcid.org/0000-0001-5356-4801
authors.initials: PH
authors.lastname: Davids
authors.affiliation: Department of Obstetrics and Gynaecology, Diakonessenhuis, Utrecht, Netherlands.
authors.forename: Petrus C
authors.identifier: http://orcid.org/0000-0002-1533-9432
authors.initials: PC
authors.lastname: Scholten
authors.affiliation: Department of Surgery, Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands.
authors.forename: Baukje
authors.identifier: http://orcid.org/0000-0001-7491-0910
authors.initials: B
authors.lastname: van den Heuvel
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Frederieke G
authors.identifier: http://orcid.org/0000-0001-5827-7000
authors.initials: FG
authors.lastname: Schaafsma
authors.affiliation: Department of Surgery, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Wilhelmus Jhj
authors.identifier: http://orcid.org/0000-0002-5402-0811
authors.initials: WJ
authors.lastname: Meijerink
authors.affiliation: Department of Surgery, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: H Jaap
authors.identifier: http://orcid.org/0000-0002-9124-3483
authors.initials: HJ
authors.lastname: Bonjer
authors.affiliation: EMGO+ Institute for Health and Care Research, Department of Public and Occupational Health, VU University Medical Center, Amsterdam, Netherlands.
authors.forename: Johannes R
authors.identifier: http://orcid.org/0000-0001-8657-0917
authors.initials: JR
authors.lastname: Anema
keywords: adnexal surgery; cholecystectomy; convalescence; cost-effectiveness; eHealth; economic evaluation; inguinal hernia surgery; mHealth; perioperative care; return to normal activities