Implementation of the preoptimisation protocol in patients presenting with obstructive colon cancer will reduce the mortality and morbidity postoperatively.
ID
Bron
Verkorte titel
Aandoening
Obstructive colon cancer
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Complication-free survival (CFS) at 90 days after hospitalization. Complication is defined here as mortality and/or development of a major complication (Clavien-Dindo classification >2).
Achtergrond van het onderzoek
Prospective registration of the implementation of the pre-optimization protocol in patients with (acute) malignant obstruction of the colon, without suspicion of perforation (tumour perforation or blow out). Pre-optimization consist of optimization of physical health, and nutritional health before definite tumour resection.
Doel van het onderzoek
Implementation of the preoptimisation protocol in patients presenting with obstructive colon cancer will reduce the mortality and morbidity postoperatively.
Onderzoeksopzet
Baseline, 90 days after hospitalization, follow-up (following the colon cancer protocol at 3/6/9/12 months post-operatively).
Onderzoeksproduct en/of interventie
Prosective registration of the implementation of the pre-optimization protocol in patients with obstructive colon cancer.
Publiek
Jeske Boeding
0162327767
jboeding@amphia.nl
Wetenschappelijk
Jeske Boeding
0162327767
jboeding@amphia.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Patients 18 years or older.
- Patients presenting with symptoms of bowel obstruction caused by (high
suspicion or histologically proven) colonic cancer.
- Patients presenting with (partial) obstruction (abdominal pain, nausea, vomiting,
diarrhoea) confirmed by the presence of a dilated colon or ileum with a computed
tomography (CT-scan).
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- Obstruction of the colon pathologically caused by benign disease.
- Obstruction of the colon caused by an extra-colonic malignancy.
- Suspicion of emergency complications caused by peritonitis due to perforation
(tumour or blow out) or sepsis.
- Rectal cancer
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL8266 |
| Ander register | Medical research Ethics Committees United (MEC-U) : W19.249 |