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.

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01313026

Enrollment

Registered

2011-03-11

Start date

2011-01-31

Completion date

2018-09-30

Last updated

2018-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rectal Cancer

Keywords

Percutaneous nerve evaluation, Transanal irrigation, Low anterior resection syndrome

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.

Interventions

PROCEDUREPercutaneous nerve evaluation

Implantation of a nerve stimulator to stimulate the sacral nerve plexus

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026