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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
Sponsor:
Information provided by (Responsible Party):
Region Skane

Brief 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.

Condition or disease
Low Anterior Resection Syndrome Rectal Cancer

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.

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Study Type : Observational
Estimated Enrollment : 1200 participants
Observational Model: Cohort
Time Perspective: Prospective
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



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All patients with rectal cancer that have undergone anterior resection for rectal cancer between Q1 2015 and Q4 2017 in Sweden
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Marie-Louise Lydrup, Assoc prof +46 768 890091 marie-louise.lydrup@skane.se
Contact: Eva Angenete, Prof +46 31 343 8410 eva.angenete@vgregion.se

Locations
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Sweden
Skane university hospital Recruiting
Malmö, Sweden
Contact: Marie-Louise Lydrup, Assoc prof         
Sponsors and Collaborators
Region Skane
Investigators
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Principal Investigator: Marie-Louise Lydrup, Assoc prof Dept of surgery, Skåne university hospital, Malmö, Sweden
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Responsible Party: Region Skane
ClinicalTrials.gov Identifier: NCT04591821    
Other Study ID Numbers: 2016/992
First Posted: October 19, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases