Recruitment

Recruitment Status
Unknown status

Inclusion Criteria

Obtaining informed consent.
Age> 18 years;
Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
Obtaining informed consent.
Age> 18 years;
Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;

Exclusion Criteria

Patients unable to follow the procedures of the Protocol or to provide informed consent.
Patients suffering from neurological disorders;
Patients who have a pacemaker or defibrillator;
...
Patients unable to follow the procedures of the Protocol or to provide informed consent.
Patients suffering from neurological disorders;
Patients who have a pacemaker or defibrillator;
Patients carrying ostomy;
Patients with Inflammatory Bowel Disease (IBD);
Patients taking antiplatelet agents or anticoagulants;
Patients with clinical or radiological evidence of local or distant tumor recurrence;

Summary

Conditions
  • Low Anterior Resection Syndrome
  • Rectal Cancer
Type
Interventional
Phase
Phase 2
Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Masking: None (Open Label)
  • Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 80 years
Gender
Both males and females

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 a...

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.

Inclusion Criteria

Obtaining informed consent.
Age> 18 years;
Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;
Obtaining informed consent.
Age> 18 years;
Patients with LARS score ≥ 21 after anterior resection of the rectum with sphincter-saving surgery for rectal cancer;

Exclusion Criteria

Patients unable to follow the procedures of the Protocol or to provide informed consent.
Patients suffering from neurological disorders;
Patients who have a pacemaker or defibrillator;
...
Patients unable to follow the procedures of the Protocol or to provide informed consent.
Patients suffering from neurological disorders;
Patients who have a pacemaker or defibrillator;
Patients carrying ostomy;
Patients with Inflammatory Bowel Disease (IBD);
Patients taking antiplatelet agents or anticoagulants;
Patients with clinical or radiological evidence of local or distant tumor recurrence;

Tracking Information

NCT #
NCT02177084
Collaborators
Not Provided
Investigators
Not Provided