Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation

Treatment of "Low Anterior Resection Syndrome" by Percutaneous Nerve Evaluation and Transanal Irrigation. A Randomized Cross Over Study.

A randomised trial testing the effect of percutaneous nerve evaluation and transanal irrigation on bowel function in patients after low anterior resection for rectal cancer.

Study Overview

• Status: Terminated
• Conditions: Rectal Cancer
• Intervention / Treatment: Procedure: Percutaneous nerve evaluation

Detailed Description

Patients will undergo anal physiological assessment and will then be randomized to either treatment arm. The first 12 weeks they will be optimized in the conservative treatment of their bowel function before beginning active treatment with TAI or PNE. After 8 and 4 weeks respectively, the treatment will stop and they will have a period of 4 weeks back on optimized conservative treatment before beginning active treatment in the other active arm.

Detailed records of bowel, micturition and sexual function and QoL will be obtained at regular intervals during the entire trial fase.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8000
    • Colorectal Surgical Department P, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Low anterior resection for rectal cancer between May 2001 and May 2011

Exclusion Criteria:

• Non-radical resection
• metastatic disease
• Chemotherapy
• Radiotherapy
• Previously treated for another cancer
• Dementia or other mental retardation/severe mental disease
• Inability to read and understand the Danish language
• Recurrent disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PNE first; patients randomised to start with PNE stimulation over 4 weeks. Then the stimulator will be removed and after a wash out period of 4 weeks they will be trained in transanal irrigation	Procedure: Percutaneous nerve evaluation; Implantation of a nerve stimulator to stimulate the sacral nerve plexus; Other Names: The Peristeen Anal Irrigation System; Medtronic nerve stimulators
Active Comparator: TAI first; Patients randomised to start with transanal irrigation treatment in 8 weeks, thereafter a wash out period of 4 weeks before being implanted with a neuro stimulator	Procedure: Percutaneous nerve evaluation; Implantation of a nerve stimulator to stimulate the sacral nerve plexus; Other Names: The Peristeen Anal Irrigation System; Medtronic nerve stimulators

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
changes in LARS score	A symptom score ranging from 0 to 42 points calculated on the basis of bowel function	baseline, 12, 16, 20, 24 and 28 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sexual function	self-reported sexual function measured by validated questionnaires	baseline, 12, 16, 20, 24 and 28 weeks
Bladder function	self-reported bladder function by validated questionnaires	baseline, 12, 16, 20, 24 and 28 weeks
Incontinence	faecal incontinence measured by wexner score and St. Marks incontinence score	baseline, 12, 16, 20, 24 and 28 weeks
Patient Satisfaction	patient satisfaction measured on a VAS	baseline, 12, 16, 20, 24 and 28 weeks

Collaborators and Investigators

• Sponsor: University of Aarhus
• Investigators: Principal Investigator: Katrine J. Emmertsen, MD, University of Aarhus

Study record dates

Study Major Dates

• Study Start: January 1, 2011
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: January 7, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 11, 2011

Study Record Updates

• Last Update Posted (Actual): December 7, 2018
• Last Update Submitted That Met QC Criteria: December 6, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Low anterior resection syndrome; Percutaneous nerve evaluation; Transanal irrigation
• Additional Relevant MeSH Terms: Pathologic Processes; Disease; Syndrome
• Other Study ID Numbers: LARS 001