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Improving Quality of Life for People with Incurable Large-Bowel Obstruction

Randomized Control Trial of Colonic Stent Insertion

Young, Christopher J. M.B.B.S., M.S.1,2; De-loyde, Katie J. M.Sc.3; Young, Jane M. Ph.D.2,3; Solomon, Michael J. M.B.B.Ch. (Hons.), M.Sc.1,2,3; Chew, Emily H. M.P.H.3; Byrne, Chris M. M.B.B.S., M.S.1,2; Salkeld, Glenn B.Bus., G.Dip.Hlth.Econ., M.P.H., Ph.D.3,4; Faragher, Ian G. M.B.B.S.5

doi: 10.1097/DCR.0000000000000431
Original Contributions: Colorectal/Anal Neoplasia
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BACKGROUND: Surgery remains the dominant treatment for large-bowel obstruction, with emerging data on self-expanding metallic stents.

OBJECTIVE: The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression.

DESIGN: This study reports on a randomized control trial (registry number ACTRN012606000199516).

SETTING: This study was conducted at Royal Prince Alfred Hospital, Sydney, and Western Hospital, Melbourne.

PATIENTS AND INTERVENTION: Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion.

MAIN OUTCOME MEASURES: The primary end point was differences in EuroQOL EQ-5D quality of life. Secondary end points included overall survival, 30-day mortality, stoma rates, postoperative recovery, complications, and readmissions.

RESULTS: Fifty-two patients of 58 needed to reach the calculated sample size were evaluated. Stent insertion was successful in 19 of 26 (73%) patients. The remaining 7 patients required a stoma compared with 24 of 26 (92%) surgery group patients (p < 0.001). There were no stent-related perforations or deaths. The surgery group had significantly reduced quality of life compared with the stent group from baseline to 1 and 2 weeks (p = 0.001 and p = 0.012), and from baseline to 12 months (p = 0.01) in favor of the stent group, whereas both reported reduced quality of life. The stent group had an 8% 30-day mortality compared with 15% for the surgery group (p = 0.668). Median survival was 5.2 and 5.5 months for the groups (p = 0.613). The stent group had significantly reduced procedure time (p = 0.014), postprocedure stay (p = 0.027), days nothing by mouth (p = 0.002), and days before free access to solids (p = 0.022).

LIMITATIONS: This study was limited by the lack of an EQ-5D Australian-based population set.

CONCLUSIONS: Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet, decreased stoma rates, reduced postprocedure stay, and some quality-of-life benefits.

1 Department of Colorectal Surgery, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

2 University of Sydney, Sydney, New South Wales, Australia

3 Surgical Outcomes Research Centre (SOuRCe), Royal Prince Alfred Hospital, Sydney, New South Wales, Australia

4 Sydney School of Public Health, University of Sydney, Sydney, New South Wales, Australia

5 Department of Colorectal Surgery, Western Hospital, Melbourne, Victoria, Australia

Funding/Support: This study was entirely funded by the National Health and Medical Rearch Council (NHMRC), Grant 457369, via Cancer Australia and the Priority-driven Collaborative Cancer Research Scheme.

Financial Disclosure: None reported.

The trial is registered with the Australian and New Zealand Clinical Trial Registry (ACTR), registration number: ACTRN01260600019951.

Poster presentation at the meeting of The American Society of Colon and Rectal Surgeons, Phoenix, AZ, April 27 to May 1, 2013 and at the meeting of the Clinical Oncology Society of Australia (COSA), Adelaide, Australia, November 12 to 14, 2013.

Correspondence: Christopher Young, M.B.B.S., M.S., SOuRCe, PO Box M157, Royal Prince Alfred Hospital, Sydney, NSW 2050, Australia. E-mail: cyoungnsw@aol.com

© 2015 The American Society of Colon and Rectal Surgeons