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A single-center and single-arm clinical study on the prevention of low anterior resection syndrome after rectal cancer surgery by acupuncture point embedding thread therapy

A single-center and single-arm clinical study on the prevention of low anterior resection syndrome after rectal cancer surgery by acupuncture point embedding thread therapy

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001611
Enrollment
Unknown
Registered
2025-08-28
Start date
2025-02-01
Completion date
Unknown
Last updated
2025-09-15

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

Conditions

rectal cancer

Interventions

Experimental Group:All patients received acupoint thread-embedding therapy before stoma retraction, once every 3 weeks for a total of 4 cycles

Sponsors

The Third Affiliated Hospital of Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age of 18-75 years old both sexes; (2) Patients with mid-low rectal cancer diagnosed by pathology and imaging underwent sphincter-preserving radical resection and prevention Sexual stoma; (3) The subjects voluntarily joined the study with good compliance and cooperated with safety and survival follow-up. (4) signing informed consent before starting study-specific screening procedures; (5) the expected survival time is more than 12 months.

Exclusion criteria

Exclusion criteria: (1) patients with severe skin diseases protein allergy or other underlying diseases not suitable for acupuncture catgut embedding treatment (2) patients requiring permanent stoma after operation; (3) complicated with severe infection (intravenous antibiotics antifungal or antiviral drugs etc.); (4) patients with severe coagulation dysfunction; (5) any of the following complications: 1) Massive gastrointestinal bleeding perforation or gastrointestinal obstruction (including paralytic ileus) 2)symptomatic heart disease (including unstable angina myocardial infarction and heart failure) 3) Uncontrolled diabetes and hypertension 4)Uncontrolled diarrhea (interferes with daily activities despite adequate treatment) 5) postoperative complications such as anastomotic leakage and anastomotic stenosis requiring reoperation; (6) unable to eat regular diet due to various reasons An abnormal disease; (7)There was preoperative anal sphincter injury anal malformation inflammatory bowel disease or other diseases that led to abnormal anal and rectal function; (8) mental disorders that may hinder adherence to the study; (9) Those who were considered unsuitable for the study by the investigators should be excluded from the study such as The investigator judged that the subjects had other factors that might lead to the forced termination of the study such as other severe diseases (including mental illness) requiring concomitant treatment severe laboratory abnormalities and family or social involvement Other factors may affect the safety of subjects or the collection of data and samples.

Design outcomes

Primary

MeasureTime frame
LARS score and incidence at 3 months after operation;

Secondary

MeasureTime frame
Wexner score for fecal incontinence;LARS score and incidence at 1 months after operation;Security Index;LARS score and incidence at 6 months after operation;EORTC QLQ-C30 score;Screening tool for psychological distress management;

Countries

China

Contacts

Public ContactJiafeng Fang

The Third Affiliated Hospital of Sun Yat-sen University

fangjf@mail.sysu.edu.cn13760660785

Outcome results

None listed

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