Prospectiv-randomizied study of transanal irrigation therapy in order to treat LARS- prophylactic use?

Not Applicable

• Conditions: Congestive urge incontinence / bowel discharge disorder after deep anterior rectal resection; R15; C20; K59.8; Faecal incontinence; Malignant neoplasm of rectum; Other specified functional intestinal disorders

• Registration Number: DRKS00011752
• Lead Sponsor: minimal invasive Chirurgie in der Wiener Privatklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-16
• Study Completion: 2018-05-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Z.n. Rectal resection with anastomotic height below 5cm from ano and protective ileostoma (+/- pouch)
The operation must be at least 3 months.
Anatomically intact healed anastomosis (radiologically and endoscopically verified), which allowed a rearward displacement of the protective stoma.
Declaration of consent of the patient to the study participation
Mental and physical readiness of the patient to participate in the study and to carry out the TAI

Exclusion Criteria

Patient rejection
The patient is not able to perform the irrigation treatment mentally and physically.
Anastomose height over 5cm from ano
Anastomotic insufficiency.
Operation is less than 3 months ago

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of the defecation episodes after stomar displacement by day and by night by the use of transanal irrigation after stomar displacement. Period of observation 3 months

Secondary Outcome Measures

Name	Time	Method
Impact of TAI on quality of life (SF-36, LARS-questionnaire)