Ulcerative colitis, IBD, Crohns colitis.
Conditions
Interventions
1. Preoperative oral antibiotics and antibiotic enema of the rectal stump prior to the surgery
2. Routine and, if intraoperatively scored necessary, tailored lengthening measures of the mesentery
3. I
Sponsors
Amsterdam UMC, location AMC
Eligibility
Inclusion criteria
Inclusion criteria: - Age above 18; - Diagnosis of Ulcerative Colitis - Diagnosis of Crohn’s disease limited to the colon without any history of perianal disease - Modified two or three stage restorative proctocolectomy with (diverted) pouch - Ability to fill in questionnaires in local language and visit out-patient-clinics. - Written informed consent.
Exclusion criteria
Exclusion criteria: Exclusion criteria: - Pregnancy - Re-do pouch operation - Known allergy to ICG, iodide allergy, or hyperthyroidism
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint of the MIRACLE study is long-term functional anastomotic integrity after pouch construction surgery for current clinical practice and after implementing an innovative peri-operative package. The primary endpoint for the latter group will be measured at 12 months postoperative. The primary endpoint for the group receiving current practice will be measured after a longer follow-up since data was collected from a retrospective cohort that underwent surgery between January 2017 and January 2019. The main study endpoint will be assessed by MR imaging a minimum of 12 months postoperative for both the prospective and retrospective study cohort. In case long term postoperative imaging is absent for patients in the retrospective cohort, prospective MR imaging is performed. It is assumed that if a chronic sinus is presence at one year, the sinus will persist. Functional anastomotic integrity is defined as absence of - A diverting (ileo)stomy - Contrast extravasation and/or presacral perianastomotic fluid collections, anastomotic fistula and severe anastomotic stricture on (CT or) MR scan or anastomotic dehiscence at endoscopy. | — |
Secondary
| Measure | Time frame |
|---|---|
| 6.1.2 Secondary endpoints 1. Clinical pouch function as defined above at 30 days and 6 months postoperatively or after defunctioning stoma closure.. 2. Quality of life and functional outcomes (prospective study group): pre-op, 90 days post-op, 6, 12 and 18 months after operation: a. Pouch functional score (PFS) APPENDIX C b. EQ-5D-5L APPENDIX D c. Cleveland QOL APPENDIX E d. IBDQ APPENDIX F e. mPDAI APPENDIX G f. IIEF APPENDIX H g. FSDS-R Female Sexual Function Index (FSFI) APPENDIX I h. Female Sexual Function Index (FSFI) APPENDIX J 3. Quality of life and functional outcomes for retrospective cohort at time of long-term postoperative MR by administering questionnaires as listed above. 4. Protocol compliance to any intervention 5. Change in management due to ICG 6. Diagnostic accuracy of CRP for anastomotic leakage 7. Efficacy of EVAC with early transanal closure of the anastomotic defect 8. Permanent stoma rate at 18 months 9. Temporary stoma rate and stoma duration at 18 months 10. Operative and post-operative complications within 30 days and 12 months (cumulative) of operation (using the Clavien-Dindo classification of surgical complications) 11. Death 12. Hospital stay and total hospital stay at one year 13. Re-intervention rate 14. Overall and stoma-related readmission 15. Cost analysis of anastomotic leakage and EVAC therapy Quality of life and pouch function will be assessed through questionnaires at baseline, 3,6, 12 and 18 months postoperative for the prospective cohort. For the retrospective cohort, questionnaires will be sent once after a minimum of 12 months postoperative. | — |
Contacts
Public ContactMaud Reijntjes
Amsterdam UMC, location AMC
Outcome results
None listed