Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
This study is currently recruiting participants.
Verified September 2012 by University of Aarhus
Sponsor:
University of Aarhus
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01313026
First received: January 7, 2011
Last updated: September 14, 2012
Last verified: September 2012
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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 2014 |
| Estimated Primary Completion Date: | June 2013 (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:
|
|
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:
|
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 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
Contacts and Locations
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: | September 14, 2012 |
| 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 May 21, 2013