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

University of Aarhus

Status: Terminated

Conditions: Rectal Cancer

Treatments: Procedure: Percutaneous nerve evaluation

Study type: Interventional

Funder types: Other

Identifiers

NCT01313026

LARS 001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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14 participants in 2 patient groups

PNE first

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous nerve evaluation

TAI first

Active Comparator group

Description:

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

Treatment:

Procedure: Percutaneous nerve evaluation