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Personalized Care Pathways for Bowel Symptoms in Rectal Cancer patients_development of E-diary

Study acronym: Treatable
StatusRecruiting
PhaseNot applicable
SponsorKU Leuven
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 15, 2026 (before its estimated July 2026 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Re-verified, no change to tracked fieldsv7
  2. Primary and study completion pushed from Aug 17, 2025 to Jul 2026v6 Show 7 more changesShow less
    • Primary endpoints: 8 to 9
    • Trial status: Completed to Recruiting
    • Enrollment target: 118 to 158
    • Study description expanded, about 91 words
    • Site details revised
    • Study arms: 5 to 6
    • Eligibility criteria expanded, about 5 words
  3. Trial status: Recruiting to Completed
    • Primary completion date changed from estimate of Oct 2025 to Aug 17, 2025
    • Study completion date changed from estimate of Mar 2026 to Aug 17, 2025
    • Site details revised
    v5
  4. Primary endpoints revised (8)v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v3
  6. Phase: Not specified to Not applicablev2 Show 6 more changesShow less
    • Start date: Feb 2024 to Apr 29, 2024
    • Primary endpoints revised (8)
    • Enrollment target: 150 to 118
    • Primary completion date: Sep 2025 to Oct 2025
    • Study completion date: Jan 2026 to Mar 2026
    • Study title expanded, about 2 words
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
KU Leuven
69 trials monitored
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Colorectal Cancer
3,394 trials monitored
See 159 trials at risk
Colorectal cancer is the 2nd and 3rd most common cancer in respectively women and men, of which about 40% is located in the rectum. The gold standard treatment for rectal cancer (RC) is a low anterior resection, combined with chemoradiotherapy. However, this treatment will negatively impact different aspects of bowel function and the patients' quality of life. These bowel symptoms often remain prevalent, even at 12 months after RC treatment. Most assessment tools are however not capable of capturing the full range or therapeutic-related evolution of these bowel symptoms. Consequently, the aim is to develop a validated bowel diary for diagnosing and evaluation of all bowel symptoms. In recent years, organ-preserving strategies such as Watch and Wait have become more widely implemented. Although these patients avoid surgical morbidity, emerging evidence shows that neoadjuvant radiotherapy alone can also cause substantial and persistent bowel dysfunction. Therefore, the study population was expanded to include patients managed with a Watch and Wait strategy in addition to those undergoing TME/PME.
Trial Details
NCT Number NCT06274190
Lead Sponsor KU Leuven
Collaborators: Universitaire Ziekenhuizen KU Leuven
Conditions
(from sponsor)		 Rectal Cancer, LARS - Low Anterior Resection Syndrome
Related terms Low Anterior Resection Syndrome, Rectal Neoplasms
Enrollment 158 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov