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Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.


N/A
18 Years
N/A
Open (Enrolling)
Both
Rectal Cancer

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Trial Information

Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.


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.


Inclusion Criteria:



- Low anterior resection for rectal cancer between May 2001 and May 2007

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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

changes in LARS score

Outcome Description:

A symptom score ranging from 0 to 42 points calculated on the basis of bowel function

Outcome Time Frame:

baseline, 12, 16, 20, 24 and 28 weeks

Safety Issue:

No

Principal Investigator

Katrine J. Emmertsen, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Aarhus

Authority:

Denmark: The Regional Committee on Biomedical Research Ethics

Study ID:

LARS 001

NCT ID:

NCT01313026

Start Date:

January 2011

Completion Date:

June 2014

Related Keywords:

  • Rectal Cancer
  • Percutaneous nerve evaluation
  • Transanal irrigation
  • Low anterior resection syndrome
  • Rectal Neoplasms

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