Rectal CancerNCT01661829
An RCT for the Effect of Biofeedback Therapy the Prevention of AR Syndrome in Rectal Cancer Patients
An observational study of Rectal Cancer, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectal Cancer
- How many people
- 56 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2012to Feb 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Rectal cancer patients who underwent sphincter saving surgery with total mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy.
Who may be able to join
- 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'
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Division of Colorectal Disease, Department of Surgery, St. Vincent's Hospital, The Catholic University of Korea
Suwon, 442-723
About this study
Official title: 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
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
- Rectal Cancer
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy) | |
| Kegel | Patients will be trained to take excersise for their anal sphincter by Kegel. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of anterior resection syndrome after stoma closure
Measured: 1 year after stoma closure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startMar 2012
- Primary completionFeb 2015
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kye Bong-Hyeon, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661829
- Sponsor's protocol ID
- KSVHCRC trial-01
- Other IDs
- Colorectal disease
- Status last verified
- Feb 2015
- First submitted
- 5 Aug 2012
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cho 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.
PubMed 34768692Kye 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.
PubMed 27149496
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01661829
- Acronym / sponsor ID
- KSVHCRC trial-01
- Conditions
- Rectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2012
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | – | –Patients will undergo biofeedback therapy between 1st adjuvant chemotherapy and stoma closure(= after 3rd ajduvant chemotherapy) |
| Kegel | – | –Patients will be trained to take excersise for their anal sphincter by Kegel. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Rectal cancer patients who underwent sphincter saving surgery with total mesorectal excision and diverting stoma after neoadjuvant chemoradiation therapy.
Key inclusion criteria (7 listed)
- rectal cancer patients
- neoadjuvant chemoradiation therapy (+)
- sphincter saving surgery with total mesorectal excision (+)
- temporary loop stoma (+)
- adult who is 17 years or older
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of anterior resection syndrome after stoma closure
Time frame: 1 year after stoma closure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
- Derived from this study: PubMed 34768692Cho 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.
- Derived from this study: PubMed 27149496Kye 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rectal Cancer, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of anterior resection syndrome after stoma closure (time frame: 1 year after stoma closure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01661829, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2015.