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Patients with rectal cancer complicated by low anterior resection syndrome who undergo anal-preserving surgery may experience severe distress in daily life due to changes in bowel function, thus requiring significant post-discharge care support from healthcare professionals. This study is a multicenter, non-blinded randomized controlled trial. One hundred patients with rectal cancer complicated by low anterior resection syndrome are planned to be randomly assigned in a 1:1 ratio from the colorectal surgery outpatient clinics of National Taiwan University Hospital, its Cancer Center, and its Yunlin Branch. They will be divided into a control group receiving routine dietary education and an experimental group receiving both routine dietary education and the use of an artificial intelligence-based dietary care system application. The artificial intelligence-based dietary care system application will be used for approximately six months. Three questionnaires will be administered at one month post-surgery (before intervention), three months post-surgery, and six months post-surgery. The questionnaires will include: a demographic data sheet, a low anterior resection syndrome score, distress inventory from altered bowel functioning, and the European Organization for Research and Treatment of Cancer QLQ-30 Scale, to verify the effectiveness of the artificial intelligence-based dietary care system application in improving bowel disturbance and quality of life in patients with rectal cancer complicated by low anterior resection syndrome.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Intelligence-based Dietary Care System | Experimental | Care program will conduct by Artificial Intelligence-based Dietary Care System. |
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| Routine care | Active Comparator | Routine dietary education during hospitalization is provided via hospital-developed electronic materials accessible through QR code scanning. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Intelligence-based Dietary Care System | Device |
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| Measure | Description | Time Frame |
|---|---|---|
| European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) | This 30-item instrument assesses cancer-related QoL across global health, five functional domains (physical, role, cognitive, emotional, and social), and nine symptom scales (fatigue, nausea/vomiting, pain, dyspnea, sleep disturbance, appetite loss, constipation, diarrhea, and financial difficulty) [22, 23]. Higher scores for functioning and global health indicate better QoL, whereas higher symptom scores denote greater symptom burden. | Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Distress Inventory for Altered Bowel Functioning (DI-ABF) | Developed by Lu et al., the 16-item DI-ABF measures distress arising from altered bowel functioning across three domains: daily life, emotional regulation, and social functioning, with higher scores reflecting greater distress. Cut point 9.5 divided to be no bowel-related distress (0-9.5) and bowel-related distress (>9.5). | Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Low Anterior Resection Syndrome (LARS) Score | Developed by Emmertsen and Laurberg [21], this tool evaluates five aspects of bowel dysfunction: flatus incontinence, fecal incontinence, bowel frequency, clustering, and urgency. Scores range from 0 to 42, with higher scores indicating more severe symptoms. Severity is categorized as no LARS (0-20), minor LARS (21-29), and major LARS (30-42). | Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ling-Chun Lu, PhD | Contact | 886-2-33665589 | lulingchun@ntu.edu.tw |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Taiwn University, College of Medicine | Taipei | 10617 | Taiwan |
For privacy protection considerations, no individual praticipant data will be shared.
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This study is a multicenter, non-blinded randomized controlled trial. One hundred patients with rectal cancer complicated by low anterior resection syndrome are planned to be randomly assigned in a 1:1 ratio from the colorectal surgery outpatient clinics of National Taiwan University Hospital, its Cancer Center, and its Yunlin Branch. They will be divided into a control group receiving routine dietary education and an experimental group receiving both routine dietary education and the use of an artificial intelligence-based dietary care system application. The artificial intelligence-based dietary care system application will be used for approximately six months. Three questionnaires will be administered at one month post-surgery (before intervention), three months post-surgery, and six months post-surgery.
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| Routine Care | Other | Content covers postoperative dietary progression, nutritional supplementation, intake principles, and food avoidance. The postoperative regimen typically advances through four stages-clear liquid, low-residue semi-liquid, low-residue soft, and regular diet-with most patients resuming normal intake within one month. Guidance emphasizes high-protein, high-calorie foods, small frequent meals, and balanced nutrition, while advising avoidance of gas-producing, odorous, coarse-fiber, greasy, spicy, pickled, and dairy products. |
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