Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University of Aarhus
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01313026
First received: January 7, 2011
Last updated: August 5, 2013
Last verified: August 2013
  Purpose

A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.


Condition Intervention
Rectal Cancer
Procedure: Percutaneous nerve evaluation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.

Resource links provided by NLM:


Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • changes in LARS score [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ] [ Designated as safety issue: No ]
    A symptom score ranging from 0 to 42 points calculated on the basis of bowel function


Secondary Outcome Measures:
  • Sexual function [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ] [ Designated as safety issue: No ]
    self-reported sexual function measured by validated questionnaires

  • Bladder function [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ] [ Designated as safety issue: No ]
    self-reported bladder function by validated questionnaires

  • Incontinence [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ] [ Designated as safety issue: No ]
    faecal incontinence measured by wexner score and St. Marks incontinence score

  • Patient Satisfaction [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ] [ Designated as safety issue: No ]
    patient satisfaction measured on a VAS


Estimated Enrollment: 20
Study Start Date: January 2011
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: PNE first
patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation
Procedure: Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Other Names:
  • The Peristeen Anal Irrigation System
  • Medtronic nerve stimulators
Active Comparator: TAI first
Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator
Procedure: Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
Other Names:
  • The Peristeen Anal Irrigation System
  • Medtronic nerve stimulators

Detailed Description:

Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.

Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Low anterior resection for rectal cancer between May 2001 and May 2011

Exclusion Criteria:

  • Non-radical resection
  • metastatic disease
  • Chemotherapy
  • Radiotherapy
  • Previously treated for another cancer
  • Dementia or other mental retardation/severe mental disease
  • Inability to read and understand the Danish language
  • Recurrent disease
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01313026

Locations
Denmark
Colorectal Surgical Department P, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Margit Majgaard, Nurse    +45 8949 7522    margmajg@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Katrine J. Emmertsen, MD University of Aarhus
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01313026     History of Changes
Other Study ID Numbers: LARS 001
Study First Received: January 7, 2011
Last Updated: August 5, 2013
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by University of Aarhus:
Percutaneous nerve evaluation
Transanal irrigation
Low anterior resection syndrome

Additional relevant MeSH terms:
Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on July 29, 2014