Multi-Interventional program for prevention and early Management of Anastomotic leakage after total mesorectal excision in Rectal cancer patIents, IMARI-trial

Multi-Interventional program for prevention and early Management of Anastomotic leakage after total mesorectal excision in Rectal cancer patIents, IMARI-trial - IMARI-trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON55903

Enrollment

488

Registered

2018-09-19

Start date

2020-02-11

Completion date

Unknown

Last updated

2026-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal cancer Rectal cancer

Interventions

The quality controlled implementation of a multi-interventional program to&nbsp

increase the one year anastomotic integrity rate in patients undergoing total&nbsp

mesorectal excision (TME) for rectal cancer, includes: 1. MBP with oral antibiotics 2. Tailored full SFM 3. Intraoperative FA using ICG 4. Routine CRP-measurement at day three postoperatively, CT-scan

contrast on indication 5. EVAC with early transanal closure of the anastomotic defect Of this program, fluorescence angiography using ICG is an intraoperative tool&nbsp

and an investigational intervention.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients with primary rectal cancer and scheduled for a total mesorectal  excision with planned restoration of bowel continuity or for completion total  mesorectal excision after previous local excision or regrowth in a watch and  wait protocol.

Exclusion criteria

Exclusion criteria: Patients not undergoing colorectal/-anal anastomosis; Local recurrent rectal cancer, or redo surgery; Locally advanced rectal cancer requiring extended or multi-visceral excision.

Design outcomes

Primary

Measure	Time frame
The primary endpoint of the IMARI-trial is anastomotic integrity at one year postoperative.	—

Secondary

Measure	Time frame
Secondary endpoints The most important secondary aim is to determine the impact on the incidence of AL within 30 and 90 days and one year post-operation. Other secondary aims include: 1. Quality of life and functional outcomes pre-op, 90 days post-op and one year after operation. 2. Protocol compliance to any intervention 3. Compliance in association to AL 4. Changes in rectal microbiome and correlation to AL 5. Change in management due to FA using ICG i. Site of proximal bowel division used for anastomosis ii. Redo anastomosis or reinforcement of anastomosis after construction anastomosis iii. Decision for diverting stoma iv. Decision for Hartmann or abdominoperineal resection rather than restorative procedure 6. Diagnostic accuracy of CRP for AL 7. Efficacy of EVAC with early transanal closure of the anastomotic defect 8. Permanent stoma rate 9. Temporary stoma rate and stoma duration 10. Operative and post-operative complications within 30 days of operation (using the Clavien- Dindo classification of surgical complications) 11. Death 12. Hospital stay 13. Reintervention rate 14. Overall and stoma-related readmission 15. Local recurrence at one year post-operation 16. Cost analysis of AL and EVAC therapy17. 3-year and 5-year oncological outcomes; Overall survival, disease free survival, distant metastasis free survival, locoregional recurrence rate	—

Measure

Time frame

Secondary endpoints The most important secondary aim is to determine the impact on the incidence of AL within 30 and 90 days and one year post-operation. Other secondary aims include: 1. Quality of life and functional outcomes pre-op, 90 days post-op and one year after operation. 2. Protocol compliance to any intervention 3. Compliance in association to AL 4. Changes in rectal microbiome and correlation to AL 5. Change in management due to FA using ICG i. Site of proximal bowel division used for anastomosis ii. Redo anastomosis or reinforcement of anastomosis after construction anastomosis iii. Decision for diverting stoma iv. Decision for Hartmann or abdominoperineal resection rather than restorative procedure 6. Diagnostic accuracy of CRP for AL 7. Efficacy of EVAC with early transanal closure of the anastomotic defect 8. Permanent stoma rate 9. Temporary stoma rate and stoma duration 10. Operative and post-operative complications within 30 days of operation (using the Clavien- Dindo classification of surgical complications) 11. Death 12. Hospital stay 13. Reintervention rate 14. Overall and stoma-related readmission 15. Local recurrence at one year post-operation 16. Cost analysis of AL and EVAC therapy17. 3-year and 5-year oncological outcomes; Overall survival, disease free survival, distant metastasis free survival, locoregional recurrence rate

—

Countries

Netherlands

Contacts

Public ContactL. Grosheide

Amsterdam UMC

l.grosheide@amsterdamumc.nl020 - 566 2714

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Feb 3, 2026