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Acupuncture in Low Anterior Resection Syndrome Treatment (AcuLARS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03916549
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : August 20, 2019
Sponsor:
Collaborator:
Vilnius University
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Low Anterior Resection Syndrome Device: Acupuncture Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Role of Traditional Acupuncture in Low Anterior Resection Syndrome Treatment - Pilot Study
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

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.




Primary Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03916549


Contacts
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Contact: Audrius Dulskas 867520094 audrius.dulskas@gmail.com

Locations
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Lithuania
National Cancer Institute Recruiting
Vilnius, Lithuania, 08406
Contact: Audrius Dulskas, MD, PhD    852786812    audrius.dulskas@gmail.com   
Principal Investigator: Tomas Aukstikalnis         
Sponsors and Collaborators
National Cancer Institute, Lithuania
Vilnius University
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Responsible Party: National Cancer Institute, Lithuania
ClinicalTrials.gov Identifier: NCT03916549    
Other Study ID Numbers: AcuLARS
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: August 20, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Syndrome
Disease
Pathologic Processes