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NCT Number: NCT03916549

Acupuncture in Low Anterior Resection Syndrome Treatment

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.

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Key information

Conditions

Low Anterior Resection Syndrome Colonic Diseases Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Cancer Institute

Vilnius, 08406, Lithuania

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

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.

Primary outcomes

  1. Bowel function changes after the treatment using Low anterior resection syndrome questionnaire

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

National Cancer Center Affiliate of Vilnius University Hospital Santaros Klinikos

Other

Collaborators

  • Vilnius University

Registry information

Official study title

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

Acronym: AcuLARS

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 16, 2019
Registry last updated
Feb 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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