- Design
- Multicentre, open-label, non-inferiority randomised trial
- Population
- 252 adults with refractory slow-transit constipation at 12 hospitals in China
- Primary outcome
- Wexner constipation score at 12 months
- Effect
- 7.01 vs 6.84; difference 0.17 (95% CI −0.93 to 1.27), non-inferior
STOPS randomised 252 adults with refractory slow-transit constipation and long-term laxative dependence at 12 Chinese hospitals to subtotal colectomy with caecorectal anastomosis or the standard total colectomy with ileorectal anastomosis. Most participants (88%) were women.
At 12 months the Wexner constipation score was 7.01 after subtotal and 6.84 after total colectomy (adjusted difference 0.17, 95% CI −0.93 to 1.27), within the non-inferiority margin of 1.32. Incontinence at three months was less common after subtotal colectomy (8.7% vs 21.4%). Perioperative morbidity (10.3% vs 12.7%) and quality of life were similar. Satisfaction at a year was very high in both arms and slightly higher after total colectomy (97.5% vs 95.8%).
Recurrent constipation after subtotal colectomy is the long-standing worry, and one year is too short to settle it. For a carefully selected patient, the subtotal operation is a reasonable option to discuss, particularly where early incontinence would matter most.
- Confirm slow transit objectively and exclude evacuation disorder before offering any colectomy for constipation.
- Discuss subtotal colectomy with caecorectal anastomosis as an option, explaining its lower early incontinence.
- Tell patients that constipation control at one year was similar, but longer-term recurrence is not yet known.
- Plan follow-up beyond one year for any patient having either operation, to capture late recurrence.
Why it matters
It offers the first randomised evidence that a less extensive colectomy controls constipation as well at a year, with less early incontinence.
Don't overread it
One-year follow-up cannot exclude later recurrence of constipation, the main concern with the subtotal operation.
The statistics, in plain English
In a non-inferiority trial the question is whether the new operation is not meaningfully worse. The confidence interval for the score difference (−0.93 to 1.27) stays below the agreed margin of 1.32, so it met that test. The small satisfaction difference is statistically significant but probably not clinically important, since both arms exceeded 95%.
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