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A multicentre randomised controlled trial of cancer rehabilitation model to improve defecation function after surgery for rectal cancer

A multicentre randomised controlled trial of cancer rehabilitation model to improve defecation function after surgery for rectal cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000821
Enrollment
Unknown
Registered
2024-12-13
Start date
2024-12-15
Completion date
Unknown
Last updated
2025-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

rectal cancer

Interventions

Cancer rehabilitation model group:cancer rehabilitation model
Usual care group:Nothing

Sponsors

Xiyuan Hospital of China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1)Aged 18-80 years regardless of gender; (2)Patients with a confirmed pathological diagnosis of rectal cancer; (3)Patients who have undergone sphincter-preserving surgery for rectal cancer and developed anorectal dysfunction resulting in abnormal defecation with a LARS score = 21; (4)Patients who are at least 6 months post-sphincter-preserving surgery or at least 3 months post-prophylactic ileostomy reversal; (5)Patients with good communication skills capable of completing questionnaires symptom scales and participating in exercises; (6)Patients with good compliance who voluntarily agree to participate and sign an informed consent form prior to enrollment.

Exclusion criteria

Exclusion criteria: (1)Patients with advanced rectal cancer who have tumors or are non-curative post-surgical patients. (2)Patients expected to undergo radiotherapy or chemotherapy during the study period. (3)Patients who have participated in other clinical trials within the past 3 months. (4)Patients with an estimated survival of less than 6 months. (5)Patients with cognitive or psychiatric disorders. (6)Patients with severe cardiovascular pulmonary renal musculoskeletal or balance disorders that prevent them from completing physical exercises.

Design outcomes

Primary

MeasureTime frame
Memorial Sloan Kettering Cancer Centre (MSKCC) Bowel Function Questionnaire;Low Anterior Resection Syndrome Scale;

Secondary

MeasureTime frame
Bristol Faecal Shape Scale;TCM spleen deficiency scale;European Organisation for Research and Treatment of Cancer Quality of Survival Core Scale;TCM Kidney deficiency scale;Modified Oxford Scale for Muscle Strength;

Countries

China

Contacts

Public ContactYufei Yang

Xiyuan Hospital of China Academy of Chinese Medical Sciences

yyf93@vip.sina.com+86 137 0136 6913

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026