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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01313026
• Other study ID #: LARS 001
• Status: Terminated
• Phase: N/A
• Start date: January 2011
• Est. completion date: September 2018

Study information

• Verified date: June 2018
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 14
• Est. completion date: September 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer

Intervention

Procedure:
• Percutaneous nerve evaluation
Implantation of a nerve stimulator to stimulate the sacral nerve plexus

Locations

Country	Name	City	State
Denmark	Colorectal Surgical Department P, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

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