Acupuncture in Low Anterior Resection Syndrome Treatment

NCT03916549 | Completed Phase 1

• 1 other identifier: AcuLARS
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Anterior Resection Syndrome

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Group 1

EXPERIMENTAL

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

Interventions

Acupuncture DEVICE

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.

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos: lead
• Vilnius University: collaborator

Study Sites (1)

National Cancer Institute

Vilnius, 08406, Lithuania

Location

Related Publications (1)

• 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.

  PMID: 34882631 RESULT

MeSH Terms

Conditions

Low Anterior Resection Syndrome

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: One group of intervention - acupuncture for LARS patients

Study Record Dates

• First Submitted: April 13, 2019
• First Posted: April 16, 2019
• Study Start: November 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: February 22, 2022

Record last verified: 2022-02

Locations

LI (1)