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

January 7, 2011
August 5, 2013
January 2011
June 2014   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01313026 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Rectal Cancer
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: 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
    Intervention: Procedure: Percutaneous nerve evaluation
  • 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
    Intervention: Procedure: Percutaneous nerve evaluation
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
June 2015
June 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Denmark
 
NCT01313026
LARS 001
Yes
University of Aarhus
University of Aarhus
Not Provided
Principal Investigator: Katrine J. Emmertsen, MD University of Aarhus
University of Aarhus
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP