No registrations found.
ID
Source
Brief title
Health condition
Obstructive colon cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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).
Secondary outcome
Complications, creation of primary anastomosis, stoma creation, radical tumour resection, operative blood loss, operation time, total hospital stay (in total, after resection or reoperation), oncological resection. With a follow up of 1 year.
Background summary
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.
Study objective
Implementation of the preoptimisation protocol in patients presenting with obstructive colon cancer will reduce the mortality and morbidity postoperatively.
Study design
Baseline, 90 days after hospitalization, follow-up (following the colon cancer protocol at 3/6/9/12 months post-operatively).
Intervention
Prosective registration of the implementation of the pre-optimization protocol in patients with obstructive colon cancer.
Jeske Boeding
0162327767
jboeding@amphia.nl
Jeske Boeding
0162327767
jboeding@amphia.nl
Inclusion criteria
- 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).
Exclusion criteria
- 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
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL8266 |
| Other | Medical research Ethics Committees United (MEC-U) : W19.249 |