An observational study in Rectum Cancer, Quality of Life and Faecal Incontinence, sponsored by Slagelse Hospital. Withdrawn at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-04.
Sponsored by Slagelse Hospital · Observational
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Among 55 studies in Rectal Neoplasms with a site in Denmark — 10 open to participants now, 18 under way, 6 of them phase 3. Rectal Neoplasms · Denmark.
Among the 55 studies in Rectal Neoplasms with a site in Denmark, this one is the 21st largest by enrollment of the 21 observational ones that give a count, is one of 5 that started in 2019, is one of 21 observational ones, and was the 28th registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →10 of the 55 studies in Rectal Neoplasms with a site in Denmark are open now. Recruiting first, the newest first:
Henry Smith · Sites in Denmark
Ages 18+
GlaxoSmithKline · Sites in Denmark, United States, Canada and 6 more countries
Ages 18+
Odense University Hospital · Sites in Denmark
Ages 18+
University of Aarhus · Sites in Denmark
Ages 18+
Vejle Hospital · Sites in Denmark
Ages 18+
A study can be open while its sites in Denmark have not opened yet or have stopped. Only those recruiting at a site in Denmark →
Of the 405 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 143 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
55 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 10 · Phase 3 11 · Phase 4 1
First in 2004; this study’s year is marked. 5 started in 2019.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 104 across the 34 interventional studies, 50 across the 21 observational. Of the 25 that completed or were terminated, 0 (0%) have results posted.
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5 of 55 have an industry lead sponsor. The 10 most frequent:
Slagelse Hospital is the lead sponsor of 21 studies on the registry; 6 are open to participants now.
Slagelse Hospital has 2 studies filed under Rectal Neoplasms — fewer than ten, so there is no comparison to draw.
4 of the studies in Rectal Neoplasms with a site in Denmark that are under way reach primary completion within a year, 3 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04095299Phase 3Vejle HospitalStandard Dose Versus High Dose of Radiotherapy in Rectal Preservation With Chemo-radiotherapy in Rectal Cancer Patients | 2026-12 |
| NCT04087421Phase 3University of AarhusComparison of Transanal Irrigation and Glycerol Suppositories in Treatment of Low Anterior Resection Syndrome | 2026-12 |
| NCT02945566Phase 3University of BirminghamCan we Save the Rectum by Watchful Waiting or TransAnal Surgery Following (Chemo)Radiotherapy Versus Total Mesorectal Excision for Early REctal Cancer? | 2027-08 |
| NCT05732389Odense University HospitalImmunotherapy in Patients With Early dMMR Rectal Cancer | 2027-07 |
Add all 4 to your calendar (.ics) → With an account.
Among the 55 studies in Rectal Neoplasms with a site in Denmark, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Also known as: Total mesorectal excision, Partial mesorectal excision
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)
Time frame: 104 weeks
Low anterior resection syndrome
Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)
Time frame: 104 weeks
Urinary incontinence
International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Time frame: 6, 26, 52 and 104 weeks
Anorectal Manometry - pressure
Maximal resting pressure Maximal squeeze pressure Maximal squeeze pressure duration
Time frame: 6, 26, 52 and 104 weeks
Anorectal Manometry - capacity
Volume capacity measurements: Maximal tolerated volume Conscious rectal sensitivity threshold Conscious rectal sensitivity Constant sensation
Time frame: 6, 26, 52 and 104 weeks
Faecal incontinence
Self-reported questionnaire - St. Marks Incontinence score (Vaizey score)
Time frame: 3, 6, 12, 26, 52 and 104 weeks
Low anterior resection syndrome
Self-reported questionnaire - Low anterior resection symptom - score (LARS-score)
Time frame: 3, 6, 12, 26 and 52 weeks
Physical activity level
physical activity section of the Danish National Health Profile
Time frame: 3, 6, 12, 26, 52 and 104 weeks
Finding meaning in life
Sources of Meaning and Meaning in Life Questionnaire (SoMe)
Time frame: 3, 6, 12, 26, 52 and 104 weeks
Physical performance
6-Minute Walk test
Time frame: 6, 26, 52 and 104 weeks
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided — Reseachers whom are interested in study data, are welcome to contact study PI.
Started Nov 2019 (actual). Primary completion is estimated for Dec 2020, 13 months after the start.
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This study is withdrawn, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
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Slagelse Hospital