Outcomes
Primary outcome
The primary outcome measure is the difference in functional outcome between the ta-IPAA and tabd-IPAA, measured by the Colorectal Functional Outcome (COREFO) questionnaire at 12 months after pouch surgery. COREFO is a validated functional score used to assess colorectal function, divided in 5 domains (Incontinence, social impact, frequency, stool related aspects and need for medication) with a total of 27 questions and a result expressed between 0 and 100, increasing with a worse function. The score was validated in 2005, including patients with IPAA.
Secondary outcomes
- The COREFO score will be assessed at 3 and 6 months after the last surgery (closure of ileostomy or pouch construction whatever is latest).
- Intra-operative and postoperative complications.
- Anastomotic leak rate
- 30-day readmission rate will be compared
- Postoperative length of stay in days will be compared.
- Quality of Life, sexual health and urinary function will be assessed using the, PROMIS Global-1030, PROMIS-SexFS31, 32 and the International Prostate Symptom Score (IPSS)33 at baseline, 3, 6 and 12 months.
- Fecal incontinence Wexner Score34 will be assessed at 3, 6 and 12 months.