Objectives

To compare the effect of uncovered and covered stents on the quality of life of people with inoperable obstructing colorectal cancer who are managed by undertaking an urgent decompression and stenting.

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Participant Population and Sample Size

A minimum of 350 patients with colorectal cancer who are managed with a palliative intent and who require an urgent decompression of their colorectal obstruction. These participants will be recruited from a minimum 20 NHS sites across the UK and overseas.

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Outcome Measures

Primary outcome:

• The Quality of Life at 3 months measured using the QLQ-C30 global health score.
• Stent patency up to 6 months post-stenting.

Secondary outcomes:

• The stenting success rate in each arm as defined by initial clinical relief of bowel obstruction
• Time to onset of short, intermediate and long-term stent related complications, measured at 30 days (short term), 1-3 months (intermediate term) and 3-12 months (long term) post-stent
• Stent related complication rates of patients undergoing chemotherapy
• The cumulative frequency and duration of stoma formation in each arm
• Overall survival
• Cost effectiveness using the outcome measure of cost per quality adjusted life year.