Acupuncture in Low Anterior Resection Syndrome Treatment (AcuLARS)

The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Low Anterior Resection Syndrome
• Intervention / Treatment: Device: Acupuncture

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 Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• Lithuania
  • Vilnius, Lithuania, 08406
    • National Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Group 1; 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.

Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bowel function changes after the treatment using Low anterior resection syndrome questionnaire	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).	6 months

Collaborators and Investigators

• Sponsor: National Cancer Institute, Lithuania
• Collaborators: Vilnius University

Publications and helpful links

General Publications

• Dulskas A, Aukstikalnis T, Kavaliauskas P, Samalavicius NE. The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment: A Pilot Study. Dis Colon Rectum. 2022 Jan 1;65(1):93-99. doi: 10.1097/DCR.0000000000002060.

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2018
• Primary Completion (Actual): December 1, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: April 13, 2019
• First Submitted That Met QC Criteria: April 13, 2019
• First Posted (Actual): April 16, 2019

Study Record Updates

• Last Update Posted (Actual): February 22, 2022
• Last Update Submitted That Met QC Criteria: February 4, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: AcuLARS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No