National Taiwn University, College of Medicine
Taipei, 10617, Taiwan
Not Yet Recruiting
NCT Number: NCT07637565
Artificial Intelligence-based Dietary Care System
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.
Not Yet Recruiting
Trial opening soon.
Get NotifiedKey information
Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Not applicable
Primary location
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Age ≥18 years.
- Clear consciousness with ability to communicate in Mandarin or Taiwanese.
- Histopathological confirmation of rectal adenocarcinoma.
- Undergoing radical rectal resection or such surgery combined with temporary stoma closure.
Exclusion criteria
- Diagnosis of other intestinal disorders, including intestinal tumors, bloating, obstruction, ulcerative colitis, or irritable bowel syndrome.
- Inability to access the internet.
- Inability to use a smartphone.
Treatment and study plan
Artificial Intelligence-based Dietary Care System
Device- Large language model-based communication for patient interaction, system guidance, analytic feedback, dietary recommendations, and referral information.
- AI-driven image analysis using regional convolutional neural networks, linked to a database of over 100,000 meals and national dietary reference standards, enabling estimation of food types, portions, and nutrient intake.
- Bowel movement tracking interface for recording time, frequency, and stool characteristics.
Routine care
OtherContent 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.
Primary outcomes
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European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
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.
Secondary outcomes
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Distress Inventory for Altered Bowel Functioning (DI-ABF)
Time frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
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).
Other outcomes
-
Low Anterior Resection Syndrome (LARS) Score
Time frame: Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.
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).
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Official study title
Effectiveness of An Artificial Intelligence-based Dietary Care System for Distress From Altered Bowel Function and Quality of Life in Rectal Cancer Patients With Low Anterior Resection Syndrome
Acronym: AI DC-system
Important dates
- Study start
- 2026
- Primary completion
- 2027
- Study completion
- 2028
- First posted
- Jun 10, 2026
- Registry last updated
- Jun 10, 2026
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.