Improving quality of life for people with incurable large-bowel obstruction: Randomized control trial of colonic stent insertion
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.