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Not yet recruiting NCT07637565

Artificial Intelligence-based Dietary Care System

No phase Interventional AI Care Device

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Artificial Intelligence-based Dietary Care System, Routine Care.
Who it may be relevant to
Registry conditions: AI Care Device. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Taiwan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official 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

Overview

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.

Interventions

  • Device Artificial Intelligence-based Dietary Care System
    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.
  • Other Routine Care
    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, pi

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Health services research

Study locations

Taiwan · 1 center
  • National Taiwn University, College of Medicine — Taipei

Identifiers

NCT: NCT07637565 · 202603195RIND

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗