Clinical trial · Observational
An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients
A Randomised Controlled Trial for the Effect of Biofeedback Therapy for the Preveintion of Anterior Resection Syndrome in Rectal Cancer Patients Who Have Undergone Low Anterior Resection With Total Mesorectal Excision Following Neoadjuvant Chemoradiation Therapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In patients who underwent sphincter preserving surgery with toal mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy for rectal cancer, the inestigators would evaluate the effect of a biofeedback therpy before stoma closure on their anorectal function after stoma closure.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Biofeedback
- description
- Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy)
- label
- Kegel
- description
- Patients will be trained to take excersise for their anal sphincter by Kegel.
Primary outcomes (1)
- measure
- Incidence of anterior resection syndrome after stoma closure
- timeFrame
- 1 year after stoma closure
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * rectal cancer patients * neoadjuvant chemoradiation therapy (+) * sphincter saving surgery with total mesorectal excision (+) * temporary loop stoma (+) * adult who is 17 years or older * patinet who aggree with our study * if woman is childbearing age, her pregnancy test shoud be indentified 'negative' Exclusion Criteria: * patients who have been enrolled to other clinical studies related to this study * patients who underwent diverting stoma before neoadjuvant chemoradiation * temporary end -ostomy (+) * uncontrolled metabolic or systemic disease * patients who do not understand the purpose of this study because of dementia or pshycologic problem * MRSA or Clostridium difficille (+) * Pregnant or during breast feeding * serious complication after sphincter saving surgery
References
Publications (2)
- DERIVEDCho HM, Kim H, Yoo R, Kim G, Kye BH. Effect of Biofeedback Therapy during Temporary Stoma Period in Rectal Cancer Patients: A Prospective Randomized Trial. J Clin Med. 2021 Nov 4;10(21):5172. doi: 10.3390/jcm10215172. PMID 34768692
- DERIVEDKye BH, Kim HJ, Kim G, Yoo RN, Cho HM. The Effect of Biofeedback Therapy on Anorectal Function After the Reversal of Temporary Stoma When Administered During the Temporary Stoma Period in Rectal Cancer Patients With Sphincter-Saving Surgery: The Interim Report of a Prospective Randomized Controlled Trial. Medicine (Baltimore). 2016 May;95(18):e3611. doi: 10.1097/MD.0000000000003611. PMID 27149496