Personalised perioperative care by e-health after intermediate-grade abdominal surgery: A multicentre, single-blind, randomised, placebo-controlled trial
The Lancet Jul 03, 2018
van der Meij E, et al. - Authors assessed the impact of a personalised e-health-care programme on return to normal activities after surgery. The return to normal activities was seen to speed up with a personalised e-health intervention after abdominal surgery vs usual care. In patients undergoing intermediate-grade abdominal, gynaecological, or general surgical procedures, implementation of this e-health programme is recommended.
Methods
- Experts conducted a multicentre, single-blind, randomised controlled trial at seven teaching hospitals in the Netherlands.
- They recruited the patients aged 18–75 years who were scheduled for laparoscopic cholecystectomy, inguinal hernia surgery, or laparoscopic adnexal surgery for a benign indication.
- Participants were randomly allocated to either the intervention or control group using computer-based randomisation lists, with stratification by sex, type of surgery, and hospital by an independent researcher.
- The intervention group participants had access to a perioperative, personalised, e-health-care programme, which managed recovery expectations and provided postoperative guidance tailored to the patient.
- Usual care and access to a placebo website containing standard general recovery advice was received by the control group.
- The participants included in this trial were unaware of the study hypothesis and were asked to complete questionnaires at five timepoints during the 6-month period after surgery.
- Time between surgery and return to normal activities was the primary outcome, measured using personalised patient-reported outcome measures.
- They conducted the intention-to-treat and per-protocol analyses.
Results
- Findings suggested that between Aug 24, 2015, and Aug 12, 2016, 344 participants were enrolled and randomly allocated to either the intervention (n=173) or control (n=171) group.
- As per data, they noted a loss of 14 participants (4%) to follow-up, with 330 participants included in the primary outcome analysis.
- Results demonstrated that in the intervention group, 21 days (95% CI 17–25) was the median time until return to normal activities and 26 days (20–32) in the control group (hazard ratio 1·38, 95% CI 1·09–1·73; p=0·007).
- Between groups, there was no difference in the complications.
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