- Design
- Multicentre, open-label, noninferiority randomised trial
- Population
- 252 adults with refractory slow-transit constipation, 12 hospitals in China
- Primary outcome
- Wexner constipation score at 12 months
- Effect
- Difference 0.17 (95% CI -0.93 to 1.27), noninferior; 3-month incontinence 8.7% vs 21.4%
The STOPS trial randomised 252 adults with refractory slow-transit constipation at 12 Chinese hospitals to subtotal colectomy with caecorectal anastomosis or total colectomy with ileorectal anastomosis. All had fewer than one spontaneous bowel movement a week and long-term laxative dependence. Most were women (88%).
At 12 months, constipation scores were similar (Wexner score 7.01 vs 6.84; difference 0.17, 95% CI -0.93 to 1.27), within the noninferiority margin. Incontinence at three months was less common after subtotal colectomy (8.7% vs 21.4%; risk difference -12.7%). Complications (10.3% vs 12.7%) and quality of life were similar. Satisfaction was very high in both arms, slightly higher after total colectomy (97.5% vs 95.8%).
The usual worry about keeping the caecum is recurrent constipation. At one year this trial does not show it, and it does show less early leakage, which matters to patients in the first months.
One year is short for a functional operation, the trial was open-label, and recurrence may yet emerge. Surgery for slow-transit constipation remains a last resort after thorough work-up, including exclusion of evacuation disorders.
- Confirm slow transit and exclude an evacuation disorder before any colectomy.
- Discuss subtotal colectomy with caecorectal anastomosis as an alternative to total colectomy.
- Tell patients early incontinence was about a third as common with the subtotal operation.
- Explain that one-year constipation control was similar, but longer follow-up is pending.
- Plan follow-up beyond a year to catch recurrent constipation.
Why it matters
Keeping the caecum may spare patients early leakage without costing constipation control at a year.
Don't overread it
One-year results only, and open-label; late recurrence of constipation has not been ruled out.
The statistics, in plain English
Noninferiority means the subtotal operation was not worse than total colectomy by more than a pre-agreed 1.32 points on the constipation score; the upper end of the interval (1.27) sat just inside that. The satisfaction difference was statistically significant but small in absolute terms.
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