Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
222 participants
OBSERVATIONAL
2016-02-01
2020-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Validation of the Moroccan Arabic Version of the Low Anterior Resection Syndrome (LARS) and Wexner Score of Continence Among Rectal Cancer Patients
NCT04128657
Experiences and Needs of Patients, Their Informal Caregiver and Healthcare Professionals Regarding LARS
NCT04896879
Rectal Cancer Survivorship: Impact of Low Anterior Resection Syndrome (LARS) on the Quality of Life
NCT06059170
International Low Anterior Resection Score Evaluation
NCT04040842
Incidence and Risk Factors of Low Anterior Resection Syndrome
NCT06359730
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
CROSS_SECTIONAL
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Rectal resection patients
Four Turkish centers participated in data collection in 2016. The inclusion criteria were rectal adenocarcinoma within 15 cm from the anal verge and LAR with either PME or TME. All patients had bowel continuity restored for at least 18 months when invited for the study. Exclusion criteria included failed R0 surgery, recurrence or dissemination, having intestinal stoma, previous cancer (except minor skin cancers) dementia and inability to speak Turkish (i.e., the need for a translator during treatment). A research assistant at each center identified the consecutive series of eligible patients for each participating consultant surgeon
Rectal Resection Patients
Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery
52 patients re-questioned to answer the same questionaire as control group
The test-retest reliability of the LARS score was evaluated by asking 52 randomly selected subgroup of eligible patients to repeat the assessment of the LARS score 2 to 4 weeks after their initial response. Agreement between tests for the LARS score category and for each of the five LARS score items is presented as proportions with 95% confidence intervals. We considered it a perfect agreement if the patient ticked the exact same response category at both tests, a moderate agreement if responses differed by one category, while 'no agreement' was applied to patients whose responses differed by two or more categories.
The intraclass correlation coefficient was used to evaluate the agreement between the initial test and the retest. The limit of agreements was calculated by using the Bland-Altman method. An ICC between 0.61 and 0.80 is considered strong agreement. A "p value" less than 0.05 was considered significant.
Rectal Resection Patients
Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Rectal Resection Patients
Patients who have had low anterior resection of rectum was categorized for their quality of life related to surgery
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* LAR with either PME or TME.
* Bowel continuity restored for at least 18 months when invited for the study.
Exclusion Criteria
* recurrence or dissemination,
* having intestinal stoma,
* previous cancer (except minor skin cancers)
* dementia and inability to speak Turkish (i.e., the need for a translator during treatment).
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Aarhus University Hospital
OTHER
Dokuz Eylul University
OTHER
Lokman Hekim University
OTHER_GOV
Ankara University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
I Ethem Gecim
Professor of Surgery
References
Explore related publications, articles, or registry entries linked to this study.
Celasin H, Akyol C, Gecim IE, Halil Elhan A, Juul T, Sokmen S, Sungurtekin U, Akyuz S. Validation of the Turkish translation of the low anterior resection syndrome (LARS) score. Tech Coloproctol. 2023 Jun;27(6):465-474. doi: 10.1007/s10151-023-02751-z. Epub 2023 Jan 18.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
3
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.