Bowel DysfunctionPMCRBDSPSNCT03009747
A Prospective Multi-Center Research on Bowel Dysfunction After Sphincter Preservative Surgery
An observational study of Bowel Dysfunction and Rectal Cancer, run by Peking University People's Hospital.
Trial summary
This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bowel Dysfunction, Rectal Cancer
- How many people
- 460 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Dec 2019
- 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 accept sphincter-preserving surgery
Who may be able to join
- Age ≥ 18 years
- Adenocarcinoma confirmed by pathology
- Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope.
- The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).
- The operation is estimated to be sphincter-preserving.
- The Eastern Cooperative Oncology Group(ECOG) performance status score of patient is ≤ 2.
- The estimated life time is not less than one year.
- The patient agree to sign the informed consent.
Who cannot join
- The patient refuse to follow research plan.
- Emergency case
- Pregnant and lactating female patient
- The patient did not accept radical resection.
- The patient did not accept first stage resection and anastomosis.
- The patient has experienced anal-rectal surgery.
Show all 11Show fewer
- The patient has experienced left colon surgery.
- The patient suffered long-existing bowel dysfunction before rectal cancer diagnosis.
- The patient was diagnosed with cognitive or communicative obstacles.
- The patient was diagnosed with serious repeated infection or other concomitance diseases.
- The patient has participated other medical research which may affect his/her bowel function.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.
- Conditions
- Bowel Dysfunction, Rectal Cancer
- Keywords
- rectal cancer, anterior resection syndrome, sphincter-preserving surgery
- Medical subject headings
- Intestinal Diseases, 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 |
|---|---|---|
| sphincter-preserving surgery | Patients meet the inclusion criteria will be enrolled into this observing group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bowel dysfunction after sphincter-preserving surgery
Measured: one year
Risk factors of bowel dysfunction after sphincter-preserving surgery
Measured: one year
Secondary outcomes (3)
Incidence of each symptoms of bowel dysfunction
Measured: one year
Prognosis of bowel dysfunction after sphincter-preserving surgery
Measured: one year
Incidence of bowel dysfunction after sphincter-preserving surgery
comparing incidences between high and low anastomsis site
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bowel DysfunctionStudies 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
- 460 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The First People's Hospital of Changzhou, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hebei Medical University Fourth Hospital, First Affiliated Hospital of Jiamusi University, China-Japan Friendship Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University (Qingdao), Peking University International Hospital
- Responsible party
- Sponsor
- Investigators
- Yingjiang Ye, M.D./ PhD, Study chair, Chinese Society of Colon and Rectal Surgeons
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03009747
- Sponsor's protocol ID
- BaS-1611
- Acronym
- PMCRBDSPS
- Status last verified
- Jan 2017
- First submitted
- 2 Jan 2017
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Publications
Liu F, Guo P, Su X, Cui M, Jiang J, Wang S, Yu Z, Zhou R, Ye Y. A Novel Remote Follow-Up Tool Based on an Instant Messaging/Social Media App for the Management of Patients With Low Anterior Resection Syndrome: Pilot Prospective Self-Control Study. JMIR Mhealth Uhealth. 2021 Mar 19;9(3):e22647. doi: 10.2196/22647.
PubMed 33739295
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomization and Clinic Cohort Observational Study From Multi Institutions on Bowel Dysfunction Following Surgery for Rectal Cancers With Sphincter Preservation
- ClinicalTrials.gov ID
- NCT03009747
- Acronym / sponsor ID
- PMCRBDSPS / BaS-1611
- Conditions
- Bowel Dysfunction, Rectal Cancer
- Keywords
- rectal cancer, anterior resection syndrome, sphincter-preserving surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 460 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- The First People's Hospital of Changzhou, Peking University Cancer Hospital & Institute, Beijing Friendship Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine, Hebei Medical University Fourth Hospital, First Affiliated Hospital of Jiamusi University, China-Japan Friendship Hospital, The First Hospital of Jilin University, The First Affiliated Hospital of Anhui Medical University, The Affiliated Hospital of the Chinese Academy of Military Medical Sciences, Xiangya Hospital of Central South University, Qilu Hospital of Shandong University (Qingdao), Peking University International Hospital
- Study start
- Jan 2017
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 4 Jan 2017 (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.
This research plans to collect rectal cancer patients after sphincter-preserving surgery from 14 institutions in China mainland, observe the incidence and risk factors about bowel dysfunction after operation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sphincter-preserving surgery | – | –Patients meet the inclusion criteria will be enrolled into this observing group |
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 accept sphincter-preserving surgery
Key inclusion criteria (8 listed)
- Age ≥ 18 years
- Adenocarcinoma confirmed by pathology
- Distance from the lowest margin of tumor to the anal verge is ≤ 12cm, confirmed by hard sigmoidoscope.
- The tumor is estimated to be resectable and confirmed by multidisciplinary team (MDT).
- The operation is estimated to be sphincter-preserving.
Key exclusion criteria (11 listed)
- The patient refuse to follow research plan.
- Emergency case
- Pregnant and lactating female patient
- The patient did not accept radical resection.
- The patient did not accept first stage resection and anastomosis.
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 bowel dysfunction after sphincter-preserving surgery
Time frame: one year
Risk factors of bowel dysfunction after sphincter-preserving surgery
Time frame: one year
3 secondary outcomes
Incidence of each symptoms of bowel dysfunction
Time frame: one year
Prognosis of bowel dysfunction after sphincter-preserving surgery
Time frame: one year
Incidence of bowel dysfunction after sphincter-preserving surgery
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
- Derived from this study: PubMed 33739295Liu F, Guo P, Su X, Cui M, Jiang J, Wang S, Yu Z, Zhou R, Ye Y. A Novel Remote Follow-Up Tool Based on an Instant Messaging/Social Media App for the Management of Patients With Low Anterior Resection Syndrome: Pilot Prospective Self-Control Study. JMIR Mhealth Uhealth. 2021 Mar 19;9(3):e22647. doi: 10.2196/22647.
- Individual participant dataSharing planned: Yes
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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.
Yingjiang Ye, M.D./ PhD study chair
Chinese Society of Colon and Rectal Surgeons
Questions about this trial
What is this clinical trial studying?
An observational study of Bowel Dysfunction and Rectal Cancer, run by Peking University People's Hospital.
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 8 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fan Liu, M.D. (+86-188-1159-0087, liufan_md@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of bowel dysfunction after sphincter-preserving surgery (time frame: one year). The study lists 2 primary outcomes in all. 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 NCT03009747, which also lists 1 linked publication.
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 Jan 2017.