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Efficiency of transanal irrigation and stimulation of a nerve of the ankle to improve symptoms and quality of life after radical surgery of rectal cancer

Not Applicable
Completed
Conditions
Patients operated for rectal cancer with sphincter preservation and poor postoperative intestinal function
Surgery
Registration Number
ISRCTN18237643
Lead Sponsor
Hospital Universitario Donostia
Brief Summary

2019 results in: https://www.ncbi.nlm.nih.gov/pubmed/31585495 (added 08/10/2019)

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
27
Inclusion Criteria

1. Patients operated on for rectal cancer with sphincter preservation and functional anastomosis at least one year before study
2. Aged 20 to 80

Exclusion Criteria

1. IBD
2. IBS
3. Pregnancy
4. Other intestinal resection segments different from the rectum
5. Metastatic disease
6. Previous history of SNS or PTNS
7. Severe postflebitic syndrome
8. Pacemaker or defibrillator
9. Neurological disorders

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Severity of LARS, measured using the Low Anterior Resection Syndrome scale (LARS) at baseline, 12, 18 and 24 weeks
Secondary Outcome Measures
NameTimeMethod
<br> Measured at baseline, 12, 18 and 24 weeks:<br> 1. Fecal incontinence, measured using Vaizey’s score<br> 2. Dysfunctional defecation, measured using Altomare’s score<br> 3. Quality of life, measured using the QLQ-C30 Score<br> 4. Patient satisfaction, measured using the VAS<br>
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