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

Quality of Life Clinical Trial

— EDFI-Cohort  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03257332
• Other study ID #: EDFI-Cohort
• Status: Withdrawn
• Start date: November 12, 2019
• Est. completion date: December 31, 2022

Study information

• Verified date: December 2020
• Source: Slagelse Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Faecal Incontinence
• Fecal Incontinence
• Low Anterior Resection Syndrome
• Quality of Life
• Rectal Neoplasms
• Rectum Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Køge	Region Zealand
Denmark	Slagelse Hospital	Slagelse	Region Zealand

Sponsors (3)

Lead Sponsor	Collaborator
Slagelse Hospital	Association of Danish Physiotherapists, Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (3)

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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Urinary incontinence	International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)	3, 6, 12, 26, 52 and 104 weeks
Other	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
Other	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
Other	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	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
Other	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
Other	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
Other	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
Other	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
Other	Anorectal Manometry - pressure	Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration	6, 26, 52 and 104 weeks
Other	Anorectal Manometry - capacity	Volume capacity measurements: Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation	6, 26, 52 and 104 weeks
Other	Faecal incontinence	Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)	3, 6, 12, 26, 52 and 104 weeks
Other	Low anterior resection syndrome	Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)	3, 6, 12, 26 and 52 weeks
Other	Physical activity level	physical activity section of the Danish National Health Profile	3, 6, 12, 26, 52 and 104 weeks
Other	Finding meaning in life	Sources of Meaning and Meaning in Life Questionnaire (SoMe)	3, 6, 12, 26, 52 and 104 weeks
Other	Physical performance	6-Minute Walk test	6, 26, 52 and 104 weeks
Primary	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	Low anterior resection syndrome	Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)	104 weeks