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STOPS Trial: Total vs Subtotal Colectomy for Slow Transit Constipation

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 16 to 14
    • Primary completion date changed from estimate of Dec 31, 2025 to May 1, 2025
    • Study completion date: Dec 31, 2028 to May 1, 2028
    v5
  2. Primary completion date: Dec 31, 2024 to Dec 31, 2025v4 Show 9 more changesShow less
    • Primary endpoint revised
    • Enrollment target: 202 to 252
    • Study sites: 11 to 16
    • Study completion date: Dec 31, 2026 to Dec 31, 2028
    • Interventions: subtotal colectomy with cecal-rectal anastomosis (Procedure), total colectomy with ileorectal anastomosis (Procedure) to Subtotal colectomy with cecal-rectal anastomosis (Procedure), Total colectomy with ileorectal anastomosis (Procedure)
    • Secondary endpoints: 11 to 12
    • Study description shortened, about 90 words
    • Publications: 5 to 6
    • Eligibility criteria shortened, about 3 words
  3. Re-verified, no change to tracked fieldsv3
  4. Secondary endpoints: 12 to 11v2
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Total colectomy with ileorectal anastomosis is a traditional surgical option for slow transit constipation (STC). Subtotal colectomy with caecorectal anastomosis have been reported to be a potential alternative approach. Thus, the optimal surgical option for STC is controversial.
Trial Details
NCT Number NCT05352074
Lead Sponsor Third Military Medical University
Conditions
(from sponsor)		 Slow Transit Constipation, Surgery
Enrollment 252 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov