Skip to content

Multicenter Randomized Controlled Study on Acupuncture Point Thread Embedding Therapy for Prevention of Low Anterior Resection Syndrome (LARS) after Rectal Cancer Surgery

Multicenter Randomized Controlled Study on Acupuncture Point Thread Embedding Therapy for Prevention of Low Anterior Resection Syndrome (LARS) after Rectal Cancer Surgery

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600122815
Enrollment
Unknown
Registered
2026-04-18
Start date
2026-04-30
Completion date
Unknown
Last updated
2026-04-20

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

Conditions

Low anterior resection syndrome after rectal cancer surgery: the main manifestations are gas or liquid fecal incontinence, defecation frequency change, clustering and urgency

Interventions

Trial Group:In addition to routine treatment before preventive stoma reversal, acupuncture point catgut embedding therapy was applied (acupoints: Guanyuan, Tianshu, Ciliao, Dachangshu, Zusanli), once
Control Group:Only routine treatment (dietary guidance, pelvic floor muscle training education) was provided before preventive stoma reversal, without acupoint catgut embedding intervention.

Sponsors

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

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-75, any gender; 2. Pathologically confirmed mid-low rectal cancer (tumor lower margin 12 months;

Exclusion criteria

Exclusion criteria: 1. Any one of the following complications: (1) massive gastrointestinal bleeding, perforation or gastrointestinal obstruction (including paralytic intestinal obstruction) (2) Severe complications such as anastomotic leakage, abdominal cavity infection, anastomotic stenosis (Clavien-Dindo>= grade III) occur early after surgery and require reoperation; 2. Patients who need a permanent stoma after the operation; 3. Uncontrolled diabetes, long-term use of steroids, and immunosuppressive status; 4. Severe comorbidities: Uncontrolled diabetes, severe cardiovascular diseases, immunosuppressive status, and long-term use of steroid drugs all affect tissue healing. 5. There is a history of inflammatory bowel disease, congenital intestinal malformations, anal sphincter injury, anal malformations or other diseases that cause abnormal function of the anus and rectum; 6. Have severe skin diseases, protein allergies or other underlying conditions that are not suitable for acupuncture and thread embedding treatment; 7. Pregnant or lactating women; 8. People who cannot eat regularly for various reasons; 9. Inability to comply with the research agreement, expected loss to follow-up: If the researcher deems it inappropriate for the subject to participate in this study, or if the researcher deems it necessary to exclude the subject from this study, for instance, if the researcher determines that the subject has other factors that may lead to the forced termination of this study, such as other serious diseases (including mental disorders) requiring combined treatment, severe laboratory test abnormalities, accompanied by family or social factors that may affect the subject's safety, Or the collection of data and samples.

Design outcomes

Primary

MeasureTime frame
Incidence of severe LARS at 3 months after stoma reversal;

Secondary

MeasureTime frame
LARS score at 1, 3, 6, and 12 months after stoma reversal;Incidence of severe LARS at 1, 3, 6, and 12 months after stoma reversal;Wexner fecal incontinence score at 1, 3, and 6 months after stoma reversal;Quality of life assessed by EORTC QLQ-C30 at 1, 3, 6, and 12 months after stoma reversal;Colorectal cancer-specific quality of life assessed by QLQ-CR29 at 1, 3, 6, and 12 months after stoma reversal;Psychological distress score assessed by DMSM at 1, 3, 6, and 12 months after stoma reversal;Anorectal manometry parameters at 3 and 12 months after stoma reversal;Gut microbiota analysis at 3 and 12 months after stoma reversal;

Countries

China

Contacts

Public ContactFang Jiafeng

The Third Affiliated Hospital of Sun Yat-sen University (Sun Yat-sen University Liver Hospital)

fangjf@mail.sysu.edu.cn+86 20 85252228

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 23, 2026