Subtotal Colectomy vs Total Colectomy for Slow-Transit Constipation: 1-Year Outcomes of the STOPS Randomized Clinical Trial.

IMPORTANCE

For patients with slow-transit constipation (STC), total colectomy with ileorectal anastomosis (TC-IRA) remains the standard surgical treatment but is frequently complicated by diarrhea, fecal incontinence, and bowel obstruction. Subtotal colectomy with cecorectal anastomosis (SC-CRA) has emerged as a promising alternative; however, recurrence of constipation remains a critical concern. High-quality evidence comparing these 2 procedures is lacking.

OBJECTIVE

To compare the 1-year Wexner Constipation Score of patients with STC who underwent SC-CRA vs TC-IRA.

DESIGN, SETTING, AND

PARTICIPANTS

This multicenter, open-label, noninferiority randomized clinical trial was conducted at 12 tertiary hospitals across 8 provinces in China from April 2022 to April 2025, with 12-month follow-up (final follow-up April 2026). Eligible participants were adults aged 18 years or older with Rome IV-defined functional constipation, fewer than 1 spontaneous bowel movement per week, and long-term laxative dependence, defined as the regular use of osmotic or stimulant laxatives, or prokinetic agents, at least 3 times weekly for 6 months or longer before enrollment. Of 272 adults assessed, 252 were randomized. These data were analyzed from March 2025 to March 2026.

INTERVENTIONS: Participants were randomly assigned in a 1:1 ratio to undergo either SC-CRA or TC-IRA.

MAIN OUTCOMES AND MEASURES: The primary outcome was the Wexner Constipation Score (WCS) at 12 months, with a prespecified noninferiority margin of 1.32 points. Secondary outcomes included fecal incontinence, morbidity, quality of life, and patient-reported satisfaction.

RESULTS

A total of 252 participants (mean age, 49.5 years; 221 female [87.7%] and 31 male [12.3%]) were randomized to undergo SC-CRA (n = 126) or TC-IRA (n = 126). At 12 months, adjusted mean (SD) WCS was 7.01 (3.31) in the SC-CRA group and 6.84 (3.68) in the TC-IRA group (adjusted mean difference, 0.17; 95% CI, -0.93 to 1.27), which fell within the prespecified noninferiority margin of 1.32 (P = .02 for noninferiority). Early postoperative incontinence at 3 months was less frequent in the SC-CRA group than in the TC-IRA group (8.7% vs 21.4%; risk difference, -12.7%; 95% CI, -21.4% to -4.0%; P = .01). Perioperative morbidity did not differ significantly between groups (10.3% vs 12.7%; risk difference, -2.4%; 95% CI, -10.3% to 5.5%; P = .41), and quality-of-life scores at 12 months were comparable. However, patient-reported satisfaction at 12 months favored the TC-IRA group (97.5% vs 95.8%; P = .03).

CONCLUSIONS AND RELEVANCE: In this randomized clinical trial among patients with refractory STC, SC-CRA was noninferior to TC-IRA with respect to the WCS at 12 months, but patient-reported satisfaction at 1 year was higher in the TC-IRA group. Longer-term follow-up is needed.

TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT05352074.