Trials / Completed
CompletedNCT03828318
Impact of a Patient-Centered Program for Low Anterior Resection Syndrome a Multicenter Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 160 (actual)
- Sponsor
- Jewish General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 99 Years
- Healthy volunteers
- Not accepted
Summary
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
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Patient Activation Booklet and nursing support for patients with LARS | The LARS Patient-Centered Program will consist of an educational booklet and nursing support made available only to patients randomized to the intervention group. |
Timeline
- Start date
- 2019-09-01
- Primary completion
- 2024-01-31
- Completion
- 2024-01-31
- First posted
- 2019-02-04
- Last updated
- 2024-11-29
Locations
6 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT03828318. Inclusion in this directory is not an endorsement.