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

NCT04591821 | Completed DMC

• 1 other identifier: 2016/992
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Anterior Resection Syndrome; Rectal Cancer

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Correlation LARS score QoL

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Age \<18 years
• Dementia,
• Unable to understand Swedish language

Sponsors & Collaborators

• Region Skane: lead

Study Sites (1)

Skane university hospital

Malmo, Sweden

Location

MeSH Terms

Conditions

Low Anterior Resection Syndrome; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Rectal Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Study Officials

• Marie-Louise Lydrup, Assoc prof

  Dept of surgery, Skåne university hospital, Malmö, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2020
• First Posted: October 19, 2020
• Study Start: February 15, 2018
• Primary Completion: September 15, 2020
• Study Completion: November 15, 2020
• Last Updated: February 18, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)