Percutaneous Tibial Nerve Stimulation in the Treatment of Anterior Resection Syndrome After Rectal Cancer Surgery

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

Study Overview

• Status: Unknown
• Conditions: Low Anterior Resection Syndrome; Rectal Cancer
• Intervention / Treatment: Device: 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:

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.

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Phase 2

Contacts and Locations

Study Locations

• Italy
  • Bologna, Italy, 40138
    • S'Orsola Malpighi University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PTNS + conservative treatment; 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	Device: PTNS
NO_INTERVENTION: conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
EORTC QLQ-CR38	Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-CR38 performed before and after treatment.	67 weeks
EORTC QLQ-C30	Secondary objectives will be evaluated by the change of the questionnaires EORTC QLQ-C30 performed before and after treatment	67 weeks
FISI	Secondary objectives will be evaluated by the change of the questionnaires FISI examinations performed before and after treatment.	67 weeks
FIQL	Secondary objectives will be evaluated by the change of the questionnaires FIQL performed before and after treatment.	67 weeks
ODS SCORE	Secondary objectives will be evaluated by the change of the questionnaires ODS score performed before and after treatment.	67 weeks
CRQoL	Secondary objectives will be evaluated by the change of the questionnaires CRQoL performed before and after treatment.	67 weeks
functional outcome	Functional outcome will be evaluated comparing manometric examinations performed before and after treatment.	67 weeks
morbidity	registration of complications after each therapy session	67 weeks

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start: July 1, 2014
• Primary Completion (ANTICIPATED): December 1, 2016

Study Registration Dates

• First Submitted: June 25, 2014
• First Submitted That Met QC Criteria: June 26, 2014
• First Posted (ESTIMATE): June 27, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): June 27, 2014
• Last Update Submitted That Met QC Criteria: June 26, 2014
• Last Verified: June 1, 2014

More Information

Terms related to this study

• Keywords: rectal cancer; low anterior resection syndrome; PTNS
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Disease; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Syndrome; Rectal Neoplasms
• Other Study ID Numbers: PTNS BO-01