NCT04591821

Bowel Dysfunction 3 Years After Anterior Resection a in a Swedish National Cohort

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,200 (actual)
• Sponsor: Region Skane · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Low Anterior Resection Syndrome
• Rectal Cancer

Timeline

• Start date: 2018-02-15
• Primary completion: 2020-09-15
• Completion: 2020-11-15
• First posted: 2020-10-19
• Last updated: 2021-02-18

Locations

1 site across 1 country: Sweden