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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02177084
Other study ID # PTNS BO-01
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received June 25, 2014
Last updated June 26, 2014
Start date July 2014

Study information

Verified date June 2014
Source St. Orsola Hospital
Contact Dajana Cuicchi, MD PhD
Phone 0516363236
Email cuicchidajana@yahoo.it
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical 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).

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


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:

1. 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

2. 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 12
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients with LARS score = 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;

- Age> 18 years;

- Obtaining informed consent.

Exclusion Criteria:

- 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.

Study Design

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


Related Conditions & MeSH terms


Intervention

Device:
PTNS


Locations

Country Name City State
Italy S'Orsola Malpighi University Hospital Bologna

Sponsors (1)

Lead Sponsor Collaborator
St. Orsola Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary EORTC QLQ-CR38 Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-CR38 performed before and after treatment. 67 weeks No
Secondary EORTC QLQ-C30 Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-C30 performed before and after treatment 67 weeks No
Secondary FISI Secondary objectives will be evaluated by the change of the questionnaires FISI examinations performed before and after treatment. 67 weeks No
Secondary FIQL Secondary objectives will be evaluated by the change of the questionnaires FIQL performed before and after treatment. 67 weeks No
Secondary ODS SCORE Secondary objectives will be evaluated by the change of the questionnaires ODS score performed before and after treatment. 67 weeks No
Secondary CRQoL Secondary objectives will be evaluated by the change of the questionnaires CRQoL performed before and after treatment. 67 weeks No
Secondary functional outcome Functional outcome will be evaluated comparing manometric examinations performed before and after treatment. 67 weeks No
Secondary morbidity registration of complications after each therapy session 67 weeks Yes
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