Artificial Intelligence-based Dietary Care System

ConditionAI Care Device

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

Artificial Intelligence-based Dietary Care System
Device
1. Large language model-based communication for patient interaction, system guidance, analytic feedback, dietary recommendations, and referral information. 2. 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. 3. Bowel movement tracking interface for recording time, frequency, and stool characteristics.
Routine Care
Other intervention
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.

Treatment groups

100 Participants

are divided into 2 treatment groups

Group A: Artificial Intelligence-based Dietary Care SystemExperimental treatment 1 intervention

Group B: Routine careActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Secondary outcomes

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).

Time frame

Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Other outcomes

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).

Time frame

Three-time frames are at one-month post-surgery (before intervention), three- months post-surgery, and six-months post-surgery.

Sponsors and contacts

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National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

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