Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery
1 other identifier
interventional
12
1 country
1
Brief 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). 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 25, 2014
CompletedFirst Posted
Study publicly available on registry
June 27, 2014
CompletedStudy Start
First participant enrolled
July 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedJune 27, 2014
June 1, 2014
2.4 years
June 25, 2014
June 26, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
67 weeks
Secondary Outcomes (8)
EORTC QLQ-CR38
67 weeks
EORTC QLQ-C30
67 weeks
FISI
67 weeks
FIQL
67 weeks
ODS SCORE
67 weeks
- +3 more secondary outcomes
Study Arms (2)
PTNS + conservative treatment
EXPERIMENTALPTNS 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 INTERVENTIONInterventions
Eligibility Criteria
You may qualify if:
- Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
- Age\> 18 years;
- Obtaining informed consent.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
S'Orsola Malpighi University Hospital
Bologna, Bologna, 40138, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr Dajana Cuicchi MD PhD
Study Record Dates
First Submitted
June 25, 2014
First Posted
June 27, 2014
Study Start
July 1, 2014
Primary Completion
December 1, 2016
Last Updated
June 27, 2014
Record last verified: 2014-06