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

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ClinicalTrials.gov Identifier: NCT03257332
Recruitment Status : Withdrawn (Not possible to include participants)
First Posted : August 22, 2017
Last Update Posted : December 4, 2020
Sponsor:
Collaborators:
Zealand University Hospital
Association of Danish Physiotherapists
Information provided by (Responsible Party):
Brian Clausen, Slagelse Hospital

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.


Condition or disease Intervention/treatment
Rectum Cancer Quality of Life Faecal Incontinence Low Anterior Resection Syndrome Procedure: Low Anterior Resection for Rectum Cancer

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: The EDFI-Cohort: Determining Early Development of Faecal Incontinence and Anorectal Muscle Function After Curative Surgery for Rectal Cancer.
Actual Study Start Date : November 12, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

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




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


Secondary Outcome Measures :
  1. Low anterior resection syndrome [ Time Frame: 104 weeks ]
    Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)


Other Outcome Measures:
  1. Urinary incontinence [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)

  2. Urinary incontinence - Urinary symptoms [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    International Consultation on Incontinence Questionnaire - Male/female Lower Urinary Tract Symptoms (ICIQ-MLUTS og ICIQ-FLUTS)

  3. Urinary incontinence - Sexual dysfunction [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    International Consultation on Incontinence Questionnaire - Male/female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ-MLUTSsex or ICIQ-FLUTSsex)

  4. Global health status/quality of life: EORTC QLQ-C30 [ Time Frame: 3, 6, 12, 26 and 52 weeks ]
    European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)

  5. Other subscales than 'global health status/quality of life': EORTC QLQ-C30 [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    European Organisation for Research and Treatment of Cancer's generic core set on quality of life (EORTC QLQ-C30)

  6. Quality of life - colorectal cancer: EORTC QLQ-CR29 [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    European Organisation for Research and Treatment of Cancer's colorectal cancer module (EORTC QLQ-CR29)

  7. Quality of life - Fatigue: EORTC QLQ-FA12 [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    European Organisation for Research and Treatment of Cancer's fatigue module (EORTC QLQ-FA12)

  8. Quality of life - INFO: EORTC QLQ-INFO25 [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    European Organisation for Research and Treatment of Cancer's information about disease and treatment module (EORTC QLQ-INFO25)

  9. Anorectal muscle function - digital examination [ Time Frame: 6, 26, 52 and 104 weeks ]
    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.

  10. Anorectal Manometry - pressure [ Time Frame: 6, 26, 52 and 104 weeks ]
    Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration

  11. Anorectal Manometry - capacity [ Time Frame: 6, 26, 52 and 104 weeks ]

    Volume capacity measurements:

    Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation


  12. Faecal incontinence [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)

  13. Low anterior resection syndrome [ Time Frame: 3, 6, 12, 26 and 52 weeks ]
    Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)

  14. Physical activity level [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    physical activity section of the Danish National Health Profile

  15. Finding meaning in life [ Time Frame: 3, 6, 12, 26, 52 and 104 weeks ]
    Sources of Meaning and Meaning in Life Questionnaire (SoMe)

  16. Physical performance [ Time Frame: 6, 26, 52 and 104 weeks ]
    6-Minute Walk test



Information from the National Library of Medicine

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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
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.
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.

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): NCT03257332


Locations
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Denmark
Zealand University Hospital
Køge, Region Zealand, Denmark, DK-4600
Slagelse Hospital
Slagelse, Region Zealand, Denmark, DK-4200
Sponsors and Collaborators
Slagelse Hospital
Zealand University Hospital
Association of Danish Physiotherapists
Investigators
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Study Chair: Søren T Skou, PhD Slagelse Sygehus
Study Chair: Ismail Gögenur, PhD Zealand University Hospital
  Study Documents (Full-Text)

Documents provided by Brian Clausen, Slagelse Hospital:
Study Protocol  [PDF] July 4, 2019
Informed Consent Form  [PDF] July 4, 2019

Additional Information:

Publications:
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Responsible Party: Brian Clausen, Physiotherapist and PhD, Slagelse Hospital
ClinicalTrials.gov Identifier: NCT03257332    
Other Study ID Numbers: EDFI-Cohort
First Posted: August 22, 2017    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Reseachers whom are interested in study data, are welcome to contact study PI.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Brian Clausen, Slagelse Hospital:
Rectum cancer
Low Anterior Rectal Syndrome
Anorectal muscle function
Additional relevant MeSH terms:
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Rectal Neoplasms
Fecal Incontinence
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases