Clinical trial · Interventional
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
After undergoing restorative proctectomy for rectal cancer, many patients are left with significant bowel dysfunction, known as Low Anterior Resection Syndrome (LARS). Increased LARS severity correlates with worse perceived global health status and quality of life (QoL). Among patients undergoing rectal resection with a permanent ostomy, there is evidence that supportive and educational interventions improve QoL, ostomy proficiency, self-efficacy and knowledge. However, evidence regarding the impact of such interventions in patients who undergo restorative proctectomy is lacking, despite the latter operation being far more frequently performed. The overall goal of this study is to evaluate the extent to which a LARS Patient-Centered Program impacts on patient-reported outcome measures (PROMs) after restorative proctectomy for rectal cancer. This is a randomized-controlled muticenter trial that will include patients who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure.
Conditions
Conditions (5)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Low Anterior Resection | — | UNRESOLVED | — |
| Low Anterior Resection Syndrome | — | UNRESOLVED | — |
| Patient Activation | — | UNRESOLVED | — |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Patient Activation Booklet and nursing support for patients with LARS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Patient Activation Arm
- interventionNames
- Other: Patient Activation Booklet and nursing support for patients with LARS
- type
- NO_INTERVENTION
- label
- Standard Care Arm
Primary outcomes (1)
- measure
- Global quality of life (QoL)
- timeFrame
- 12 months
- description
- Measured by EORTC QLQ-C30
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Adult patients (\>=18 years-old) who have undergone restorative proctectomy for neoplastic disease (benign or malignant) located in the rectum (0-15cm from the anal verge) with a diverting ostomy and who are scheduled for ostomy closure Exclusion Criteria: * Patients from whom clear and informed consent cannot be obtained * Patients unable to read and comprehend English or French * Patients who cannot be contacted by telephone * Patients who have undergone major colonic resection in addition to their proctectomy * Patients on active chemotherapy or radiotherapy treatment
References
Publications (1)
- DERIVEDGarfinkle R, Loiselle CG, Park J, Fiore JF Jr, Bordeianou LG, Liberman AS, Morin N, Faria J, Ghitulescu G, Vasilevsky CA, Bhatnagar SR, Boutros M. Development and evaluation of a patient-centred program for low anterior resection syndrome: protocol for a randomized controlled trial. BMJ Open. 2020 May 30;10(5):e035587. doi: 10.1136/bmjopen-2019-035587. PMID 32474427