Method: 87 patients undergoing ileostomy creation surgery were randomized in a 1:1 ratio to standard of care (SOC) or Intervention (INV) between 5/2016 and 7/2018. A randomization sequence was developed using block size of 4, stratified by type of stoma (loop ileostomy vs. end ileostomy) and BMI (≤30 vs. >30). SOC group (N=44) received pre-operative Wound Ostomy Continence Nurse (WOCN) education, WOCN stoma marking, inpatient WOCN ostomy teaching, home healthcare and 30-day WOCN clinic follow-up. INV group (N=43) received SOC plus 72-hour post-discharge phone call from WOCN. Primary outcome was healthcare utilization (emergency room, office visit, hospitalization) in 30-days following discharge. Secondary outcomes included incidence of peristomal skin complications (PSC) and DET (Discoloration, Erosion, Tissue Overgrowth) score at 30-day WOCN assessment.
Results: Primary outcome was collected on 77/87 randomized patients. Healthcare utilization within 30-days occurred in 47%(19/40) in SOC group and 43%(16/37) in INV group (χ2(1)=0.14,p=0.71). Incidence of PSC at 30-days was measured in 71 patients with 64%(23/36) in SOC and 57%(20/35) in INV group (χ2(1)=0.34,p=0.56). There was no significant difference between SOC group (n=35, 4.3±3.6) and INV group (n=33, 3.4±3.3) regarding DET scores (p=0.33).
Conclusion: These findings suggest that a phone call within 72-hours of discharge does not significantly prevent the need for healthcare utilization or PSCs. Despite pre-operative WOCN education, WOCN stoma marking, WOCN inpatient teaching and home healthcare, 43%(16/37) of patients report healthcare utilization and 60%(43/71) report PSC at 30-days following surgery. This study suggests that clinical follow-up with WOCN, prior to 30-days, may be indicated to reduce healthcare utilization and incidence of PSC.