TABLE 3.
Screening | Randomization | Post‐allocation | |||||
---|---|---|---|---|---|---|---|
Time point | D‐10 a | Postoperative time | M1 | M2 | M3 | M6 | In case of SC b |
Enrolment | |||||||
Eligibility screen | × | ||||||
Informed consent | × | ||||||
Administrative and baseline data | × | ||||||
Allocation | × | ||||||
Interventions | |||||||
Intervention group | |||||||
Control group | |||||||
Assessments | |||||||
Stoma‐QoL questionnaire | × | × | × | × | × | × | |
EQ‐5D‐5L questionnaire | × | × | × | × c | |||
Rate of rehospitalization d | × | × | × | ||||
Patients' satisfaction | × | × | × | × | × | ||
Cost evaluation | × | × | × | ||||
Location of patient (hospital, home etc.) | × | × | × | × | × | × | |
How to recover the medical material | × | × | × | × | × | ||
Possible assistance in providing care | × | × | × | × | × | ||
Relationship with the health provider | × | × | × | × | × | ||
Relationship with the ST | × | × | × | × | × | ||
Control of the material by the patient | × | × | × | × | × |
Abbreviations: D‐10, 10 days before surgery; QoL, quality of life; SC, stoma closure; ST, stoma therapist.
Stoma made less than 10 days ago or during the current hospitalization.
Between day − 2 and day + 2 from stoma closure.
Only before 3 months.
Rehospitalization due to a stoma problem.