NCT03257332: EDFI-Cohort

Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.

Withdrawn Last updated 4 December 2020

What this trial tests

trial testing Low Anterior Resection for Rectum Cancer in Rectum Cancer. Withdrawn.

Timeline

12 November 2019

Primary endpoint
31 December 2020

31 December 2022

Quick facts

Lead sponsor	Slagelse Hospital
Status	Withdrawn
Study type	OBSERVATIONAL
Start date	12 November 2019
Primary completion	31 December 2020
Estimated completion	31 December 2022
Sites	2 locations across Denmark

Drugs / interventions tested

• Low Anterior Resection for Rectum Cancer

Conditions studied

• Rectum Cancer — all drugs for Rectum Cancer →
• Quality of Life — all drugs for Quality of Life →
• Faecal Incontinence — all drugs for Faecal Incontinence →
• Low Anterior Resection Syndrome — all drugs for Low Anterior Resection Syndrome →

Sponsor

Slagelse Hospital

Who can join

18 and older, any sex, with Rectum Cancer or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background:

Patients treated for rectal cancer are in high risk of developing poor quality of life and faecal incontinence. Faecal incontinence has a negative impact on quality of life. However, there is limited knowledge on how to prevent it. Known exposures are ; age at surgery, gender, tumor height, pre-operative radiotherapy, surgical technique and temporary stoma. In order to evaluate the underlying mechanisms of faecal incontinence, it is central to evaluate the anorectal muscle function for sensory and motor impairment. Exposures representing different constructs in the biopsychosocial model are likewise likely to be associated with quality of life and faecal incontinence. These exposures include sexual dysfunction, urinary incontinence, fatique, physical inactivity and finding meaning in life. There are to our knowledge, no records on these relationships from prior to surgery to 2 years after. These biopsychosocial exposures are central to include when developing strategies that can prevent poor quality of life and faecal incontinence for patients treated for rectal cancer.

Purpose:

The primary purpose of the EDFI-Cohort study is to determine how several variables (surgical technique, anorectal muscle function, faecal incontinence, urinary incontinence, sexual dysfunction, fatigue, physical activity and finding meaning in life) develop over time and predicts quality of life. Secondary how it predicts LARS-score in patients with rectal cancer from prior to surgery to 2 years after primary treatment.

Methods:

We will include subjects diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy. The cohort aim to recruit all eligible patients in a one year period. We estimate to recruit 70 patients.

Self-reported outcomes will be collected with a series of validated questionnaires that subjects will be asked to complete 6 times during the two year study at 3, 6, 12, 26 78 and 104 weeks. Outcomes include: Quality of life using (EORTC QLQ-C30) (primary outcome), (CR29) and (FA12), bowel related quality of life (LARS-score) (secondary outcome), faecal incontinence (Vaizey score), urinary incontinence (ICIQ-UI), (MLUTS/FLUTS) and (MLUTSsex/FLUTSsex), physical activity level from Danish National Health Profile and finding meaning in life (SOME).

Objective measures will be collected at 6 weeks, 6 months, 12 months and 24 months and include: Anorectal manometry that measures anorectal muscle function and rectal perception, a digital examination of anorectal muscle function using the Digital Rectal Examination Scoring System (DRESS) and the six-minute walk test a measure of submaximal exercise capacity.

We plan to analyze the EDFI-Cohort study as repeated measures with both simple and multiple linear regression models for the continuous data. We plan to adjust for known confounders and variables related to treatment.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.