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

Rectal Cancer Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02177084
• Other study ID #: PTNS BO-01
• 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. 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

• Low Anterior Resection Syndrome
• Rectal Cancer

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