The use of Biofeedback and electrostimulation therapy in patients with low anterior resection syndrome after rectal carcinoma and rectal resection to enhance quality of life and fecal continence

Not Applicable

• Conditions: Rectal CarcinomaFecal incontinence; C20; R15; Malignant neoplasm of rectum; Faecal incontinence

• Registration Number: DRKS00011765
• Lead Sponsor: Krankenhaus Agatharied

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-10
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

patients with rectal carcinoma who underwent anterior or low anterior resection in Aagatharied Hospital between 1999 and 2017

Fecal Incontinence after Parks (I-III)

Total mesorectal Excision in patients with low and middle rectal cancer ( 0-6 and 6-12 cm from the anal verge) or partial mesorectal excision in patients with rectal carcinom 12-16cm from the anal verge.

Earliest time for evalutation:6 weeks after last surgery

Loop ileostomy has to have been reversed

The Patient has to be able to cognitive and physically perform Biofeedback und middle frequent electrostimulation therapy.

Exclusion Criteria

Participation in another interventionel study

Patients with local recurrence or Progress of the cancer

Patients with vulnerable rectum mucosa, inflammatory changes or Stenosis in the rectum

Patients under 18

Pregnancy

Patients that are not mentally or physically capable of consenting to the study

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement of fecal incontinence in the CCS Score (Fecal incontinence Score), measured 6 weeks, 3,6 and 12 months after beginn of therapy<br><br>

Secondary Outcome Measures

Name	Time	Method
ARS Score ( Low anterior resection Syndrome Score)<br>FiQuOL ( Fecal Incontinence Quality of Life)<br>Anal manometry<br>Tumor classification UICC<br>Quality of TME (total mesorectal excision) Mercury<br>Hight of anastomosis<br>Complications of surgery ( Clavien Dindo )<br>Time between surgery and begin of therapy<br>Neoadjuvant Radiochemotherapy