Table 3

Schedule of events

EventsBaselinePreop study visit5 days before surgeryDay of surgery (preop)Day of surgery (intraop)POD 1POD 2POD 3POD 4POD 5POD 6–10After discharge30-day phone F/U
Study proceduresTrial consent
Device training
Device distribution
Self-administered stimulation
Stimulation diary
Blinding poll
Data collectionEligibility CRF
Baseline CRF
Operative CRF
Gastrointestinal function CRF
Follow-up CRF
Substudies*Optional substudy consents
Inflammatory response study
Blood only: ✓; blood and fluid: ✓✓
✓✓
Small bowel motility study (MRI)
Qualitative substudy (participant or non-participant interview)
  • *Substudies are optional and undertaken at the lead site only.

  • CRF, case report form; F/U, follow-up; POD, postoperative day.