No registrations found.
ID
Source
Brief title
Health condition
Anastomotic leakage after rectal cancer surgery
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint of the IMARI-trial is anastomotic integrity at one year postoperative.
Secondary outcome
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 outcomes include quality of life, protocol compliance, changes in rectal microbiome, FA details and other postoperative outcomes.
Background summary
Multicenter prospective clinical effectiveness trial, whereby current local practice (control cohort) will be subsequently compared to the results of a multi-interventional program (intervention cohort) in patients undergoing total mesorectal excision (TME) for rectal cancer. This program includes:
1. Mechanical bowel preparation with oral antibiotics
2. Tailored full splenic flexure mobilization
3. Intraoperative fluorescence using indocyanine
4. Routine CRP-measurement at day three postoperatively, CT-scan with rectal contrast on indication
5. EVAC with early transanal closure of the anastomotic defect
Study objective
To increase the one year anastomotic integrity rate in patients undergoing total mesorectal excision (TME) for rectal cancer by the routine and quality controlled implementation of a multi-interventional program.
Study design
Preoperative. 3 and 4 days postoperative. 1, 3 and 12 months postoperative
Intervention
1. Mechanical bowel preparation with oral antibiotics
2. Tailored full splenic flexure mobilization
3. Intraoperative fluorescence using indocyanine
4. Routine CRP-measurement at day three postoperatively, CT-scan with rectal contrast on indication
5. EVAC with early transanal closure of the anastomotic defect
Inclusion criteria
1) Patients with a diagnosis of primary rectal cancer with the lower border below the level of the sigmoid take-off on MRI, or regrowth in a watch and wait protocol, or undergoing completion/salvage surgery after local excision;
2) Age above 18;
3) Able to fill in questionnaires in Dutch and to come to out-patient-clinic visits;
4) Written informed consent.
Exclusion criteria
1) Patients not undergoing resection with colo-rectal/anal anastomosis;
2) Local recurrent rectal cancer;
3) Locally advanced rectal cancer requiring extended or multi-visceral excision;
4) Synchronous colonic resections;
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8261 |
| CCMO | NL67600.018.18 |
| OMON | NL-OMON55903 |