Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer. (EDFI-Cohort)

The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.

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.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life; Low Anterior Resection Syndrome; Rectum Cancer; Faecal Incontinence
• Intervention / Treatment: Procedure: Low Anterior Resection for Rectum Cancer

• Study Type: Observational

Contacts and Locations

Study Locations

• Denmark
  • Region Zealand
    • Køge, Region Zealand, Denmark, DK-4600
      • Zealand University Hospital
    • Slagelse, Region Zealand, Denmark, DK-4200
      • Slagelse Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects for the EDFI-Cohort study will be recruited during 2019 and 2020 from Department of Surgery, Slagelse, and Zealand University Hospital, Køge. Subjects need to be diagnosed with rectal cancer and have received curative surgery (low anterior resection) with/without adjuvant (radiation/chemo) therapy.

Description

Inclusion Criteria:

• Diagnosis of rectal cancer
• Low anterior resection (e.g. not limited to total mesorectal excision (TME) or partial mesorectal excision (PME))
• Ability to communicate in Danish
• Adults (> 18 years of age)
• American Society of Anaesthesiologists (ASA) score: I-IV.

Exclusion Criteria:

• ASA score of: V-VI.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
EDFI Cohort; Subjects should have received surgery for rectal cancer (low anterior resection).	Procedure: Low Anterior Resection for Rectum Cancer; Subjects should have received curative surgery for rectal cancer (low anterior resection) with/with-out adjuvant (radiation/chemo) therapy.; Other Names: Total mesorectal excision; Partial mesorectal excision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global health status/quality of life: EORTC QLQ-C30	European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)	104 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Low anterior resection syndrome	Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)	104 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary incontinence	International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)	3, 6, 12, 26, 52 and 104 weeks
Urinary incontinence - Urinary symptoms	International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)	3, 6, 12, 26, 52 and 104 weeks
Urinary incontinence - Sexual dysfunction	International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)	3, 6, 12, 26, 52 and 104 weeks
Global health status/quality of life: EORTC QLQ-C30	European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)	3, 6, 12, 26 and 52 weeks
Other subscales than 'global health status/quality of life': EORTC QLQ-C30	European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)	3, 6, 12, 26, 52 and 104 weeks
Quality of life - colorectal cancer: EORTC QLQ-CR29	European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)	3, 6, 12, 26, 52 and 104 weeks
Quality of life - Fatigue: EORTC QLQ-FA12	European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)	3, 6, 12, 26, 52 and 104 weeks
Quality of life - INFO: EORTC QLQ-INFO25	European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)	3, 6, 12, 26, 52 and 104 weeks
Anorectal muscle function - digital examination	Maximal resting pressure Maximal squeeze pressure Endurance squeeze - max squeeze pressure or longest time Latency (rate of force development), number of rectal muscle contractions/squeezes in 15 sec test.	6, 26, 52 and 104 weeks
Anorectal Manometry - pressure	Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration	6, 26, 52 and 104 weeks
Anorectal Manometry - capacity	Volume capacity measurements: Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation	6, 26, 52 and 104 weeks
Faecal incontinence	Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)	3, 6, 12, 26, 52 and 104 weeks
Low anterior resection syndrome	Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)	3, 6, 12, 26 and 52 weeks
Physical activity level	physical activity section of the Danish National Health Profile	3, 6, 12, 26, 52 and 104 weeks
Finding meaning in life	Sources of Meaning and Meaning in Life Questionnaire (SoMe)	3, 6, 12, 26, 52 and 104 weeks
Physical performance	6-Minute Walk test	6, 26, 52 and 104 weeks

Collaborators and Investigators

• Sponsor: Slagelse Hospital
• Collaborators: Zealand University Hospital; Association of Danish Physiotherapists
• Investigators: Study Chair: Søren T Skou, PhD, Slagelse Sygehus; Study Chair: Ismail Gögenur, PhD, Zealand University Hospital

Publications and helpful links

General Publications

• Emmertsen KJ, Laurberg S; Rectal Cancer Function Study Group. Impact of bowel dysfunction on quality of life after sphincter-preserving resection for rectal cancer. Br J Surg. 2013 Sep;100(10):1377-87. doi: 10.1002/bjs.9223.
• Lai X, Wong FK, Ching SS. Review of bowel dysfunction of rectal cancer patients during the first five years after sphincter-preserving surgery: a population in need of nursing attention. Eur J Oncol Nurs. 2013 Oct;17(5):681-92. doi: 10.1016/j.ejon.2013.06.001. Epub 2013 Jul 17.
• Ma B, Gao P, Song Y, Zhang C, Zhang C, Wang L, Liu H, Wang Z. Transanal total mesorectal excision (taTME) for rectal cancer: a systematic review and meta-analysis of oncological and perioperative outcomes compared with laparoscopic total mesorectal excision. BMC Cancer. 2016 Jul 4;16:380. doi: 10.1186/s12885-016-2428-5.

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 17, 2017
• First Submitted That Met QC Criteria: August 17, 2017
• First Posted (Actual): August 22, 2017

Study Record Updates

• Last Update Posted (Actual): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 2, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Rectum cancer; Low Anterior Rectal Syndrome; Anorectal muscle function
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Fecal Incontinence
• Other Study ID Numbers: EDFI-Cohort

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Reseachers whom are interested in study data, are welcome to contact study PI.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No