Incidence and Risk Factors of Low Anterior Resection SyndromeNCT05373602
LARS for Chinese Patients
An observational study of Incidence and Risk Factors of Low Anterior Resection Syndrome, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
Trial summary
Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Incidence and Risk Factors of Low Anterior Resection Syndrome
- What is being tested?
- LARS questionnaire
- How many people
- 261 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to May 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: rectal cancer patients
Who may be able to join
- Patients diagnosed as rectal cancer and underwent radical laparoscopic LAR and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team
Who cannot join
- either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to LARS questionnaire
Trial locations and contacts
1 site in 1 country.
China1 site
the Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510630
About this study
Official title: The Incidence and Risk Factors of Low Anterior Resection Syndrome: Basing on Data of Chinese Patients From a Single Center
Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Considering varieties and differences of patient characteristics between Chinese patients and the western ones, this retrospective study aims to investigate the incidence of LARS in Chinese patients undergoing laparoscopic LAR, and to explore perioperative risk factors that might be associated with major LARS. Consequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with LARS questionnaire. Incidence of LARS and patient data were collected and analyzed.
- Being tested
- LARS questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LARS questionnaireDiagnostic test
Eligible participants were issued with LARS questionnaire (Chinese version) by E-mail, message, phone or face to face interview.
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of LARS
incidence of Low Anterior Resection Syndrome
Measured: at least 1 months postoperatively
incidence of major LARS
incidence of major Low Anterior Resection Syndrome
Measured: at least 1 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study startJan 2015
- Primary completionMay 2021
- Study completionMay 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Incidence and Risk Factors of Low Anterior Resection SyndromeStudies 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
- Retrospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongbo Wei, Third Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373602
- Sponsor's protocol ID
- LARS001
- Status last verified
- May 2022
- First submitted
- 10 May 2022
- Last updated
- 13 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Risk Factors of Low Anterior Resection Syndrome: Basing on Data of Chinese Patients From a Single Center
- ClinicalTrials.gov ID
- NCT05373602
- Acronym / sponsor ID
- LARS001
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Third Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- May 2021 (actual)
- First posted
- 13 May 2022 (actual)
- 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.
Low anterior resection syndrome (LARS) frequently occurs in patients undergoing low anterior resection (LAR). However, the incidence, exact mechanism and risk factors of major LARS largely variate in different studies. Considering varieties and differences of patient characteristics between Chinese patients and the western ones, this retrospective study aims to investigate the incidence of LARS in Chinese patients undergoing laparoscopic LAR, and to explore perioperative risk factors that might be associated with major LARS. Consequent patients undergoing laparoscopic LAR and free from disease recurrence from January 2015 to May 2021 were issued with LARS questionnaire. Incidence of LARS and patient data were collected and analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- rectal cancer patients
Key inclusion criteria (1 listed)
- Patients diagnosed as rectal cancer and underwent radical laparoscopic LAR and straight colorectal/coloanal anastomosis (with or without a protective stoma) by a same surgical team
Key exclusion criteria (1 listed)
- either local or distal recurrence, severe complications such as postoperative anastomotic leakage, failure of protective stoma closure, data missed and no responding to LARS questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LARS questionnaireEligible participants were issued with LARS questionnaire (Chinese version) by E-mail, message, phone or face to face interview. | Diagnostic test | – |
Primary outcome
incidence of LARS
Time frame: at least 1 months postoperatively
incidence of Low Anterior Resection Syndrome
incidence of major LARS
Time frame: at least 1 months postoperatively
incidence of major Low Anterior Resection Syndrome
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 13 May 2022.
- Individual participant dataSharing planned: No
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 Incidence and Risk Factors of Low Anterior Resection Syndrome, run by Third Affiliated Hospital, Sun Yat-Sen University at 1 site in China.
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 1 inclusion and 1 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 13 May 2022. 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 China. 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 LARS (time frame: at least 1 months postoperatively). 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?
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 13 May 2022.