Obstructing colorectal cancer Cancer Malignant neoplasm of colon
Conditions
Interventions
An open randomised controlled trial where patients will be randomised between emergency surgery and endoluminal stenting. All patients will present in the acute setting and will be put forward for urg
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Both male and female patients (no specific age limit) 2. Radiologically proven colonic obstruction of left colon/upper rectum presumed secondary to a carcinoma 3. Patient considered sufficiently fit for surgery if allocated
Exclusion criteria
Exclusion criteria: 1. Patients with signs of peritonitis and/or perforation 2. Patients with right iliac fossa tenderness and features of incipient caecal perforation 3. Patients with obstruction in the rectum that may require neoadjuvant therapy (i.e. tumours in the mid or lower rectum) 4. Patients who are unfit for surgical treatments or refuse surgical treatment 5. Pregnant patients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measures as of 13/03/2017: 1. Length of hospital stay, measured using site-completed trial-specific Case Report Forms at discharge and 12-month follow-up 2. 30-day mortality, measured using mortality data from ONS (also included on CRFs) at 30 days Previous primary outcome measures: 1. Length of hospital stay 2. 30-day mortality 3. Presence and duration of a stoma | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 13/03/2017: Data collection points were baseline (screening/randomisation/procedure); discharge; 6 weeks; every 3 months in first year; every 6 months to 3 years: 1. Presence and duration of stoma, measured using intraoperative and discharge Forms (emergency and elective surgery), annual follow up forms 2. Stenting completion and complication rates, measured using stent insertion and stent follow up forms, following stenting at day 7 and day 28 post-stenting and up to 12 months 3. Anastomosis rate, measured using intraoperative form and discharge form, following emergency and elective surgery up to 12 months and then annually 4. 6-month survival, measured using ONS mortality data (also collected on CRFs) at 6 months 5. Quality of life, measured using patient-completed EORTC QLQ C30, QLQ CR29 and EQ-5D at discharge, 3 months and 1 year 6. Proportion disease free at 3 years, measured using ONS Cancer Registry data (also collected on CRFs) at 3 years 7. Length of stay in HRU and ITU, measured using intraoperative and discharge forms following emergency and elective surgery, and discharge form following stenting 8. Perioperative morbidity, measured using intraoperative and discharge forms for emergency and elective surgery 9. Cost benefit analysis, assessed using discharge forms (for bed days) 10. Rate of adjuvant chemotherapy and adherence to chemotherapy protocol, measured using annual follow-up forms Previous secondary outcome measures: 1. Stenting completion and complication rate (arm A only). Complications will be recorded between 24 hours and 7 days (early) and between 7 and 28 days (late). 2. Anastomosis rate, recorded during surgery 3. Quality of life, measured by the EQ-5D and the Eu | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Outcome results
None listed