Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort
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|ClinicalTrials.gov Identifier: NCT04591821|
Recruitment Status : Recruiting
First Posted : October 19, 2020
Last Update Posted : October 19, 2020
|Condition or disease|
|Low Anterior Resection Syndrome Rectal Cancer|
All patients who have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 have been identified in the Swedish Colorectal Cancer Registry (SCRCR). Three years after surgery the patients were sent a questionnaire including the LARS (Low Anterior Resection Syndrome)-score, the quality of life questionnaire EORTC QLQ 30 and CR29 in addition to a questionnaire regarding prevalence of remaining stoma.The patient cohort will be divided into two groups operated with total (TME) or partial (PME) mesorectal excision for further analyses. Patients with a stoma will be analysed separately.
Prevalence of major LARS and Quality of Life, QoL, 3 years after anterior resection will be assessed by the EORTC QLQ-C30 and by calculation of LARS Score with categories "no" (0-20 points), "minor" (21-29) and "major" (30-42). The LARS score will be dichotomized into the categories no/minor and major LARS.
Stoma function will be evaluated by the stoma scale in EORTC QLQ-CR29.
|Study Type :||Observational|
|Estimated Enrollment :||1200 participants|
|Official Title:||Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort|
|Actual Study Start Date :||February 15, 2018|
|Actual Primary Completion Date :||September 15, 2020|
|Estimated Study Completion Date :||November 15, 2020|
- Low Anterior Resection Syndrome score ( LARS Score) [ Time Frame: 3 years ]Prevalence of low anterior resection syndrome (LARS) 3 years after low anterior resection for rectal cancer, assessed by the validated instrument LARS score consisting of 5 questions with a total score of between 4 and 42. .0-20 corresponds to no LARS, 21-29 to minor LARS and 30-42 to major LARS.
- QoL [ Time Frame: 3 years ]Quality of life measured by the validated EORTC (European Organisation for Research and Treatment of Cancer) questionnaires QLQ 30 (Quality of life questionnaire 30) consisting of 30 questions and CR 29 (colirecti 29), a specific questionnaire assessing quality of life in colorectal cancer patients, consisting of 29 questions. Both QLQ 30 and CR 29 include symptom scales and functional scales from 0-100 with lower scores on symptom scales indicating better quality of life and higher scores on functional scales indicating better quality of life.
- Correlation LARS score QoL [ Time Frame: 3 years ]Correlation between low anterior resection syndrome (LARS) assessed by the validated instrument LARS score consisting of 5 questions with a total score of between 4 and 42, 0-20 corresponding to no LARS, 21-29 to minor LARS and 30-42 to major LARS, and the bowel dysfunction scale in EORTC (European Organisation for Research and Treatment of Cancer) questionnaire CR29 (colirecti 29) consisting of 6 questions with a total score between 6 and 24 with higher score indicating worse function.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04591821
|Contact: Marie-Louise Lydrup, Assoc prof||+46 768 email@example.com|
|Contact: Eva Angenete, Prof||+46 31 343 firstname.lastname@example.org|
|Skane university hospital||Recruiting|
|Contact: Marie-Louise Lydrup, Assoc prof|
|Principal Investigator:||Marie-Louise Lydrup, Assoc prof||Dept of surgery, Skåne university hospital, Malmö, Sweden|