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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04591821
• Other study ID #: 2016/992
• Status: Completed
• Start date: February 15, 2018
• Est. completion date: November 15, 2020

Study information

• Verified date: February 2021
• Source: Region Skane
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1200
• Est. completion date: November 15, 2020
• Est. primary completion date: September 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of rectal cancer in Sweden

• Operated on with anterior resection between Q1 2015 and Q4 2017 in Sweden, with or without defunctioning stoma

Exclusion Criteria:

• Age <18 years

• Dementia,

• Unable to understand Swedish language

Related Conditions & MeSH terms

• Intestinal Diseases
• Low Anterior Resection Syndrome
• Rectal Cancer

Locations

Country	Name	City	State
Sweden	Skane university hospital	Malmö

Sponsors (1)

Lead Sponsor	Collaborator
Region Skane

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years
Primary	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.	3 years
Secondary	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.	3 years