Rectal CancerNCT01313026
Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation
A study testing Percutaneous nerve evaluation in people with Rectal Cancer, run by University of Aarhus at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- What is being tested?
- Percutaneous nerve evaluation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2011to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Low anterior resection for rectal cancer between May 2001 and May 2011
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Colorectal Surgical Department P, Aarhus University Hospital
Aarhus, 8000
About this study
Official title: 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.
Read the 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.
- Conditions
- Rectal Cancer
- Being tested
- Percutaneous nerve evaluation
- Keywords
- Percutaneous nerve evaluation, Transanal irrigation, Low anterior resection syndrome
- Medical subject headings
- Rectal Neoplasms, Low Anterior Resection Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous nerve evaluationProcedure or surgery
Also called The Peristeen Anal Irrigation System, Medtronic nerve stimulators
Implantation of a nerve stimulator to stimulate the sacral nerve plexus
| Study group | Role | What they receive |
|---|---|---|
| PNE first | Active comparator | 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 Receives: Procedure: Percutaneous nerve evaluation |
| TAI first | Active comparator | 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 Receives: Procedure: Percutaneous nerve evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in LARS score
A symptom score ranging from 0 to 42 points calculated on the basis of bowel function
Measured: baseline, 12, 16, 20, 24 and 28 weeks
Secondary outcomes (4)
Sexual function
self-reported sexual function measured by validated questionnaires
Measured: baseline, 12, 16, 20, 24 and 28 weeks
Bladder function
self-reported bladder function by validated questionnaires
Measured: baseline, 12, 16, 20, 24 and 28 weeks
Incontinence
faecal incontinence measured by wexner score and St. Marks incontinence score
Measured: baseline, 12, 16, 20, 24 and 28 weeks
Patient Satisfaction
patient satisfaction measured on a VAS
Measured: baseline, 12, 16, 20, 24 and 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2011 (estimated)
- Study startJan 2011
- Primary completionFeb 2018
- Study completionSep 2018
Why it stopped: Difficult to recruit participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Katrine J. Emmertsen, MD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01313026
- Sponsor's protocol ID
- LARS 001
- Status last verified
- Jun 2018
- First submitted
- 7 Jan 2011
- Last updated
- 7 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.
- ClinicalTrials.gov ID
- NCT01313026
- Acronym / sponsor ID
- LARS 001
- Conditions
- Rectal Cancer
- Keywords
- Percutaneous nerve evaluation, Transanal irrigation, Low anterior resection syndrome
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficult to recruit participants
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 11 Mar 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PNE first | Active comparator | Procedure: Percutaneous nerve evaluationpatients 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 |
| TAI first | Active comparator | Procedure: Percutaneous nerve evaluationPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Low anterior resection for rectal cancer between May 2001 and May 2011
Key exclusion criteria (8 listed)
- Non-radical resection
- metastatic disease
- Chemotherapy
- Radiotherapy
- Previously treated for another cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Percutaneous nerve evaluationAlso: The Peristeen Anal Irrigation System, Medtronic nerve stimulatorsImplantation of a nerve stimulator to stimulate the sacral nerve plexus | Procedure or surgery | PNE first, TAI first |
Primary outcome
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
4 secondary outcomes
Sexual function
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Bladder function
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Incontinence
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Patient Satisfaction
Time frame: baseline, 12, 16, 20, 24 and 28 weeks
Results and safety
The study was stopped early (reason given: Difficult to recruit participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katrine J. Emmertsen, MD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous nerve evaluation in people with Rectal Cancer, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 7 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Difficult to recruit participants). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in LARS score (time frame: baseline, 12, 16, 20, 24 and 28 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2018.