Acupuncture in Low Anterior Resection Syndrome Treatment (AcuLARS)

National Cancer Institute, Lithuania

Status and phase: Completed; Phase 1

Conditions: Low Anterior Resection Syndrome

Treatments: Device: Acupuncture

Study type: Interventional

Funder types: Other

Identifiers

NCT03916549

AcuLARS

Details and patient eligibility

About

Acupuncture has it's role in treating patients with fecal incontinence and diarrhea-predominant irritable bowel syndrome. There is no trial or case-report assessing it's role in treatment of Low anterior resection syndrome.

Full description

Colorectal cancer is common in Western countries. For thirty years rectal cancer treatment is standardized: patients are undergoing low anterior resection with mesorectal excision +/- (chemo)radiotherapy. Unfortunately around 80% of patients undergoing low anterior resection will experience complex bowel dysfunction including fecal incontinence, soiling, urgency, incomplete evacuation, fragmented defecation and impaired rectal sensation known as low anterior resection syndrome (LARS) causing a "toilet dependence" which severely affects quality of life.

Still there is no standardized treatment for LARS.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• patients over 18 year
• signed written consent
• patients experiencing major low anterior resection syndrome
• patients at least one year following the surgery

Exclusion criteria

• allergy to stainless steal
• implanted pacemaker
• current skin infection
• needle phobia
• metastatic disease to the central nervous system (brain, spinal cord)
• at the same time, application of smecta, dicetel, cisapride or traditional Chinese medicine;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Group 1

Experimental group

Description:

The patients with bowel dysfunction following low anterior resection performed at least 1 year ago will undergo acupuncture. The acupuncture procedure is performed by one well trained person, 1 time per week in total of 10 weeks on the same day time. Sterile, disposable, stainless steel acupuncture needles (40x0.25 mm diameter) were inserted to corporal acupoints, with initial gentle stimulation by quick rotation of 1080°, after then leaving needle in located place for twenty minutes. Needling deep - 0.5-1 cm. If the intent was to invigorate - the needle was inserted to the flow of energy; if harmonization needed - the needle was placed perpendicular to the point flow of energy; if sedation was needed, needles were placed against to the flow of energy on channel. The selection of acupoints was based according by traditional Chinese medicine, literature findings.

Treatment:

Device: Acupuncture