Acupuncture in Low Anterior Resection Syndrome Treatment

Phase 1

Completed

• Conditions: Low Anterior Resection Syndrome
• Interventions: Device: Acupuncture

• Registration Number: NCT03916549
• Lead Sponsor: National Cancer Institute, Lithuania

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2018-11-01
• Study First Submitted: 2019-04-13
• Study First Submitted QC: 2019-04-13
• Study First Posted: 2019-04-16
• Primary Completion: 2019-12-01
• Study Completion: 2019-12-31
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-04
• Last Update Posted: 2022-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Group 1	Acupuncture	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.

Primary Outcome Measures

Name	Time	Method
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire	6 months	Bowel function assessment using Low anterior resection syndrome questionnaire Bowel function following low anterior resection surgery for rectal cancer will be assessed using Low anterior resection syndrome score (LARS score - simple 5 question questionnaire). LARS score is a tool consisting of five items, which are as follows: incontinence due to flatus (score range from 0 to 7), incontinence due to liquid stools (score range from 0 to 3), frequency of bowel movements (score range from 0 to 5), clustering (score range from 0 to 11) and urgency (score range from 0 to 16). The severity of each item is calculated on a scale ranging from 0 to 42, with a score of 0-20 (no LARS), 21-29 (minor LARS) and 30-42 (major LARS).

Trial Locations

Locations (1)

National Cancer Institute; 🇱🇹 Vilnius, Lithuania