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.
ID
Bron
Verkorte titel
Aandoening
Anastomotic leakage after rectal cancer surgery
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary endpoint of the IMARI-trial is anastomotic integrity at one year postoperative.
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
Preoperative. 3 and 4 days postoperative. 1, 3 and 12 months postoperative
Onderzoeksproduct en/of interventie
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
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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;
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8261 |
| CCMO | NL67600.018.18 |
| OMON | NL-OMON55903 |