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

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ClinicalTrials.gov Identifier: NCT01313026
Recruitment Status : Recruiting
First Posted : March 11, 2011
Last Update Posted : October 26, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Rectal Cancer Procedure: Percutaneous nerve evaluation

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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.
Study Start Date : January 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2019
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. changes in LARS score [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ]
    A symptom score ranging from 0 to 42 points calculated on the basis of bowel function


Secondary Outcome Measures :
  1. Sexual function [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ]
    self-reported sexual function measured by validated questionnaires

  2. Bladder function [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ]
    self-reported bladder function by validated questionnaires

  3. Incontinence [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ]
    faecal incontinence measured by wexner score and St. Marks incontinence score

  4. Patient Satisfaction [ Time Frame: baseline, 12, 16, 20, 24 and 28 weeks ]
    patient satisfaction measured on a VAS


Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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): NCT01313026


Locations
Denmark
Colorectal Surgical Department P, Aarhus University Hospital Recruiting
Aarhus, Denmark, 8000
Contact: Margit Majgaard, Nurse    +45 7846 5113    margmajg@rm.dk   
Sponsors and Collaborators
University of Aarhus
Investigators
Principal Investigator: Katrine J. Emmertsen, MD University of Aarhus
More Information

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01313026     History of Changes
Other Study ID Numbers: LARS 001
First Posted: March 11, 2011    Key Record Dates
Last Update Posted: October 26, 2016
Last Verified: October 2016

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