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The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with fecal incontinence and/or chronic constipation (of heterogenous origin).
The aim of this study is to investigate the efficacy of low-volume irrigation on bowel function among patients with FI and/or CC (of heterogenous origin). Further, the aim is to investigate if low volume irrigation can change the negative impact that symptoms of FI and/or CC (of heterogenous origin) have on the patients' daily activities and QoL. Additionally, the aim is to investigate the short-term and long-term discontinuation rates in relation to treatment with low-volume irrigation. Finally, the aim is to investigate the daily time-consumption, the practical challenges and the side effects related to low-volume irrigation. The study period is six weeks and the participants will be instructed to irrigate once daily with Qufora IrriSedo MiniGo.
This study is an interventional study. Patients with FI and/or CC of heterogenous origin, seen in the Nurse-led Clinic for Bowel Dysfunction at the Pelvic Floor Unit, Aarhus University hospital, will be included. Patients will be offered transanal irrigation as a treatment option. Patients presenting with Bristol stool type 6-7 should be offered conservative treatment to optimize the stool consistency. If patients can be regulated to a Bristol stool type 1-5, they can be invited to participate in the study. If necessary, regulation of the stool consistency in patients presenting with Bristol stool type 1-2 is an option, before introducing transanal irrigation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low-volume irrigation | Experimental | The patients will be instructed to irrigate once daily at a fixed time for 6 weeks. The patients will be instructed to use the irrigation 30 min after breakfast, capitalizing on the gastrocolic response; however, should this not fit in with the individual's lifestyle, then an alternative time of the day may be used. Preferably shortly after a large meal. The patients should fill the pump with 180 milliliters (a full pump) and irrigate with a volume of 160 milliliters of water. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low-volume irrigation | Device | Qufora IrriSedo MiniGo |
|
| Measure | Description | Time Frame |
|---|---|---|
| 11-point Likert scale | The present bowel functions impact on daily activities (0: no, 10: maximum influence) | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 11-point Likert scale | The present bowel functions impact on daily activities (0: no, 10: maximum influence) | 3 months, 6 months, 12 months |
| 11-point Likert scale | Assessment of the present bowel function (0: no bowel dysfunction, 10: severe bowel dysfunction) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mira Mekhael, MD | Aarhus University Hospital | Study Chair |
| Therese Juul, PhD | Aarhus University Hospital | Study Chair |
| Klaus Krogh, DMSc, Phd | Aarhus University Hospital | Study Chair |
| Paul Vollebregt, PhD, MD | Queen Mary University of London/Amsterdam University | Study Chair |
| Louise Schmidt Grau, MD | Aarhus University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery | Aarhus | Denmark |
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| ID | Term |
|---|---|
| D003248 | Constipation |
| D005242 | Fecal Incontinence |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012002 | Rectal Diseases |
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| 6 weeks, 3 months, 6 months, 12 months |
| 11-point Likert scale | The present bowel functions impact on overall QoL (0: no influence, 10: maximum influence) | 6 weeks, 3 months, 6 months, 12 months |
| 11-point Likert scale | General satisfaction with present bowel function (0: perfect satisfaction, 10: total dissatisfaction) | 6 weeks, 3 months, 6 months, 12 months |
| 11-point Likert scale | General satisfaction with current treatment (0: perfect satisfaction, 10: total dissatisfaction) | 6 weeks, 3 months, 6 months, 12 months |
| The St. Mark's fecal incontinence score | Participants suffering from fecal incontinence | 6 weeks |
| The Fecal Incontinence Quality of Life Scale | Participants suffering from fecal incontinence | 6 weeks |
| PAC-SYM score | Participants suffering from constipation | 6 weeks |
| The Patients Assessment of Constipation Quality of life | Participants suffering from constipation | 6 weeks |
| The 5-level EQ-5D (EQ-5D-5L) index score | For all patients | 6 weeks |
| Five-point ordinal scale | Self-rated change in bowel function measured on a five-point ordinal scale (much worse, a little worse, unchanged, a little better, much better). | 6 weeks |
| Discontinuation rates | Time until discontinuation and reasons for discontinuation. | 6 weeks, 3 months, 6 months, 12 months |
| Correlation for the primary outcome | Correlation between score change in primary outcome and the patients' subjective perception of present bowel function rated on a 11-point Likert scale (0: no bowel dysfunction, 10: severe bowel dysfunction) and the patients' evaluation of the efficacy of low-volume irrigation on bowel function rated on a scale from great improvement to great worsening | 6 weeks |
| Correlation for SMIS and PAC-SYM | Correlation between the SMIS or PAC-SYM and the patients' subjective perception of present bowel function rated on a 11-point Likert scale (0: no bowel dysfunction, 10: severe bowel dysfunction) and the patients' evaluation of the efficacy of low-volume irrigation on bowel function rated on a scale from great improvement to great worsening | 6 weeks |
| Practicalities and adverse effects | Descriptive analyses of volume and duration of irrigation, efficacy of irrigation with regards to evacuation, practical challenges and adverse effects. | 6 weeks, 3 months, 6 months, 12 months |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |