Clinical trial NCT03257332: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Surgery for Rectal Cancer.
Official title: The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Rectum Cancer
Quality of Life
Faecal Incontinence
Low Anterior Resection Syndrome
Keywords: Rectum cancer
Low Anterior Rectal Syndrome
Anorectal muscle function
Lead sponsor: Slagelse Hospital
Sponsor class: OTHER
Collaborators: name: Zealand University Hospital
name: Association of Danish Physiotherapists
First posted: 2017-08-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Global health status/quality of life: EORTC QLQ-C30
timeFrame: 104 weeks
Secondary outcomes:
measure: Low anterior resection syndrome
timeFrame: 104 weeks
Other outcomes:
measure: Urinary incontinence
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Urinary incontinence - Urinary symptoms
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Urinary incontinence - Sexual dysfunction
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Global health status/quality of life: EORTC QLQ-C30
timeFrame: 3, 6, 12, 26 and 52 weeks
measure: Other subscales than 'global health status/quality of life': EORTC QLQ-C30
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Quality of life - colorectal cancer: EORTC QLQ-CR29
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Quality of life - Fatigue: EORTC QLQ-FA12
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Quality of life - INFO: EORTC QLQ-INFO25
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Anorectal muscle function - digital examination
timeFrame: 6, 26, 52 and 104 weeks
measure: Anorectal Manometry - pressure
timeFrame: 6, 26, 52 and 104 weeks
measure: Anorectal Manometry - capacity
timeFrame: 6, 26, 52 and 104 weeks
measure: Faecal incontinence
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Low anterior resection syndrome
timeFrame: 3, 6, 12, 26 and 52 weeks
measure: Physical activity level
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Finding meaning in life
timeFrame: 3, 6, 12, 26, 52 and 104 weeks
measure: Physical performance
timeFrame: 6, 26, 52 and 104 weeks
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
state: Region Zealand
city: Slagelse
country: Denmark
facility: Slagelse Hospital
state: Region Zealand
Study officials:
affiliation: Slagelse Sygehus
name: Søren T Skou, PhD
role: STUDY_CHAIR
affiliation: Zealand University Hospital
name: Ismail Gögenur, PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.