An observational study in Low Anterior Resection Syndrome and Rectal Cancer, sponsored by Region Skane. Completed at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-02-18.
Sponsored by Region Skane · Observational
The primary objectives are to evaluate the prevalence of LARS and Quality of Life in rectal cancer patients 3 years after anterior resection, to investigate if anastomotic technique is a risk factor for major LARS and to study the prevalence of colostomy 3 years after anterior resection and evaluate stoma function according to the stoma scale in EORTC QLQ-CR29.
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.
963 studies on the registry are indexed under Intestinal Diseases; 174 are open to participants now.
This study's enrollment of 1,200 is above the median of 140 across 377 observational studies indexed under Intestinal Diseases.
Browse Intestinal Diseases studies →Region Skane is the lead sponsor of 372 studies on the registry; 113 are open to participants now.
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All patients with rectal cancer that have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 in Sweden
Exclusion Criteria:
Low Anterior Resection Syndrome score ( LARS Score)
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.
Time frame: 3 years
QoL
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.
Time frame: 3 years
Correlation LARS score QoL
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.
Time frame: 3 years
Plan to share: No
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This study is completed, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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Region Skane