Rectal CancerPhase 2NCT02177084
Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery
A Phase 2 study testing PTNS in people with Rectal Cancer and Low Anterior Resection Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Rectal Cancer, Low Anterior Resection Syndrome
- What is being tested?
- PTNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteItaly
- Study dates
- Jul 2014to Dec 2016
- Phase
- Phase 2
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
- Age> 18 years;
- Obtaining informed consent.
Who cannot join
- Patients carrying ostomy;
- Patients with clinical or radiological evidence of local or distant tumor recurrence;
- Patients suffering from neurological disorders;
- Patients with Inflammatory Bowel Disease (IBD);
- Patients who have a pacemaker or defibrillator;
- Patients taking antiplatelet agents or anticoagulants;
- Patients unable to follow the procedures of the Protocol or to provide informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
S'Orsola Malpighi University Hospital
Bologna, Bologna, 40138
Dajana Cuicchi, MD PhD, cuicchidajana@yahoo.it
About this study
The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).
The secondary aims are the evaluation of the following parameters:
- Effect of PTNS on manometric parameters
- Effect of PTNS on quality of life
- Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
- Safety of PTNS
Read the detailed description
The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:
Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment
The study is divided into two phases:
- PRETREATMENT PHASE The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
- Collection of personal data
- Collection of medical records
- Collection of data relating to the intervention of anterior resection of the rectum
- Verification of the criteria for inclusion / exclusion
- Collection of informed consent
- Administration of the questionnaires European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal 38 (EORTC QLQ-CR38), Faecal incontinence severity index (FISI); Fecal incontinence quality of life questionnaire (FIQL), Obstructed defaecation syndrome (ODS) score questionnaire and Constipation-related quality of life questionnaire (CRQoL)
- Endoanal ultrasound
- Anorectal manometry
- PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.
It is expected to enroll approximately 12 patients.
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Being tested
- PTNS
- Keywords
- PTNS, rectal cancer, 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.
PTNSDevice
| Study group | Role | What they receive |
|---|---|---|
| PTNS + conservative treatment | Experimental | PTNS consists in the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface electrode is placed under th arch of the foot. Both electrodes are connected to the neurostimulator that generates electricity. A neuromodulation session lasts 30 minutes.
The treatment plan includes 12 weekly sessions, followed by two sessions at 2-week intervals and the last one after one month. Two additional sessions of reinforcement (top-up) are provided at intervals of 6 months or earlier in case of worsening of symptoms Receives: Device: PTNS |
| conservative treatment | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
LARS score
The primary end point is the evaluation of the results of the two interventions in functional terms, by comparing the LARS score calculated first at the end and after 12 months of treatment, according to the following classification:
- No LARS: a score between 0 and 20
- LARS mild: score between 21:29
- LARS severe: a score between 30 and 42
Measured: 67 weeks
Secondary outcomes (8)
EORTC QLQ-CR38
Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-CR38 performed before and after treatment.
Measured: 67 weeks
EORTC QLQ-C30
Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-C30 performed before and after treatment
Measured: 67 weeks
FISI
Secondary objectives will be evaluated by the change of the questionnaires FISI examinations performed before and after treatment.
Measured: 67 weeks
FIQL
Secondary objectives will be evaluated by the change of the questionnaires FIQL performed before and after treatment.
Measured: 67 weeks
ODS SCORE
Secondary objectives will be evaluated by the change of the questionnaires ODS score performed before and after treatment.
Measured: 67 weeks
CRQoL
Secondary objectives will be evaluated by the change of the questionnaires CRQoL performed before and after treatment.
Measured: 67 weeks
functional outcome
Functional outcome will be evaluated comparing manometric examinations performed before and after treatment.
Measured: 67 weeks
morbidity
registration of complications after each therapy session
Measured: 67 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2014 (estimated)
- Study startJul 2014
- Primary completionDec 2016 (estimated)
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 IRCCS Azienda Ospedaliero-Universitaria di BolognaThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cuicchi Dajana, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02177084
- Sponsor's protocol ID
- PTNS BO-01
- Status last verified
- Jun 2014
- First submitted
- 25 Jun 2014
- Last updated
- 27 Jun 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery
- ClinicalTrials.gov ID
- NCT02177084
- Acronym / sponsor ID
- PTNS BO-01
- Conditions
- Rectal Cancer, Low Anterior Resection Syndrome
- Keywords
- PTNS, rectal cancer, low anterior resection syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Dec 2016 (estimated)
- First posted
- 27 Jun 2014 (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.
The study aims to evaluate the efficacy of percutaneous tibial nerve stimulation (PTNS) associated with conservative therapy (arm A) for the treatment of low anterior resection syndrome (LARS) compared with only conservative therapy (arm B).
The secondary aims are the evaluation of the following parameters:
- Effect of PTNS on manometric parameters
- Effect of PTNS on quality of life
- Effect of PTNS on the severity of fecal incontinence and / or obstructed defecation
- Safety of PTNS
Detailed description
The study is a prospective randomized clinical trial that compares two treatments in patients with LARS:
Arm A: PTNS + conservative treatment (based on predominant symptom) Arm B: only conservative treatment
The study is divided into two phases:
- PRETREATMENT PHASE The patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer, will be submitted during the first visit of the study to :
- Collection of personal data
- Collection of medical records
- Collection of data relating to the intervention of anterior resection of the rectum
- Verification of the criteria for inclusion / exclusion
- Collection of informed consent
- Administration of the questionnaires European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Cancer 30 (EORTC QLQ-C30), European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire Colorectal 38 (EORTC QLQ-CR38), Faecal incontinence severity index (FISI); Fecal incontinence quality of life questionnaire (FIQL), Obstructed defaecation syndrome (ODS) score questionnaire and Constipation-related quality of life questionnaire (CRQoL)
- Endoanal ultrasound
- Anorectal manometry
- PHASE OF TREATMENT During the treatment phase, data related to the treatment and any treatment related-complications will be recorded on a special form Bowel function and quality of life will be assessed using the same questionnaires at the end of treatment. Even anorectal manometry will be repeated at the end of treatment.
It is expected to enroll approximately 12 patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PTNS + conservative treatment | Experimental | Device: PTNSPTNS consists in the insertion of a small electrode above the medial malleolus adjacent to the posterior tibial nerve. An adhesive surface electrode is placed under th arch of the foot. Both electrodes are connected to the neurostimulator that generates electricity. A neuromodulation session lasts 30 minutes. The treatment plan includes 12 weekly sessions, followed by two sessions at 2-week intervals and the last one after one month. Two additional sessions of reinforcement (top-up) are provided at intervals of 6 months or earlier in case of worsening of symptoms |
| conservative treatment | No intervention | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
- Age> 18 years;
- Obtaining informed consent.
Key exclusion criteria (7 listed)
- Patients carrying ostomy;
- Patients with clinical or radiological evidence of local or distant tumor recurrence;
- Patients suffering from neurological disorders;
- Patients with Inflammatory Bowel Disease (IBD);
- Patients who have a pacemaker or defibrillator;
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 |
|---|---|---|
| PTNS | Device | PTNS + conservative treatment |
Primary outcome
LARS score
Time frame: 67 weeks
The primary end point is the evaluation of the results of the two interventions in functional terms, by comparing the LARS score calculated first at the end and after 12 months of treatment, according to the following classification: * No LARS: a score between 0 and 20 * LARS mild: score between 21:29 * LARS severe: a score between 30 and 42
8 secondary outcomes
EORTC QLQ-CR38
Time frame: 67 weeks
EORTC QLQ-C30
Time frame: 67 weeks
FISI
Time frame: 67 weeks
FIQL
Time frame: 67 weeks
ODS SCORE
Time frame: 67 weeks
CRQoL
Time frame: 67 weeks
functional outcome
Time frame: 67 weeks
morbidity
Time frame: 67 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2014.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing PTNS in people with Rectal Cancer and Low Anterior Resection Syndrome, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 3 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 27 Jun 2014. 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 Italy. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dajana Cuicchi, MD PhD (0516363236 ext. +39, cuicchidajana@yahoo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
LARS score (time frame: 67 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 27 Jun 2014.