Trial of colonic stenting for large bowel obstruction

Surgery versus stent insertion for the improved quality of life for non-curable colorectal cancer - large bowel obstruction

Status

Not yet recruiting

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12606000199516

Enrollment

142

Registered

2006-05-26

Start date

2006-05-30

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

For patients with malignant bowel obstruction that cannot be cured, palliative surgery is often required to relieve the obstruction. This usually requires the formation of a stoma or opening where the bowel is brought to the suface of the skin. An alternative to surgery is the placement of a metal tube or stent through the obstruction to allow the passage of stool. As these surgical interventions are palliative the most important outcomes are those relating to the patients quality of life. This study will determine whether patients' quality of life is greater following stent insertion than surgery to relieve bowel obstruction. It will also compare complication rates and resource utilisation for each intervention. An economic evaluation will determine the relative cost-effectiveness of the 2 procedures.

Interventions

This study will compare the outcomes of colorectal surgery (bowel resection and possible stoma formation) versus colonic stent insertion using Ultraflex or Wallfex Precision Colonic Stent manufactured by Boston Scientific (TGA approved in Australia) to determine optimal management of non-curable colorectal cancer. Comparisons will be made between quality of life, length of stay, complications and cost to identify which group has the optimal outcome. The study will be conducted over 3 years.

Study design

Allocation

Randomised controlled trial

Intervention model

Factorial

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

All adult patients who present with malignant large bowel obstruction proven radiologically & deemed non-curable by surgical interention.

Exclusion criteria

If a patient is unfit for surgical iintervention (ASA grade iv & v), require urgent laparotomy due to perferation or ischaemia of the bowel, have evidence of synchronous & seperate sites of the small & large bowel, or are cognitively impaired or otherwise unable to give informed consent.

Outcome results