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

Not Applicable

Terminated

• Conditions: Rectal Cancer
• Interventions: Procedure: Percutaneous nerve evaluation

• Registration Number: NCT01313026
• Lead Sponsor: University of Aarhus

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-07
• Study First Submitted QC: 2011-03-09
• Study First Posted: 2011-03-11
• Primary Completion: 2018-02
• Status Verified: 2018-06
• Study Completion: 2018-09
• Last Update Submitted: 2018-12-06
• Last Update Posted: 2018-12-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
PNE first	Percutaneous nerve evaluation	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
TAI first	Percutaneous nerve evaluation	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

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Colorectal Surgical Department P, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark