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| Name | Class |
|---|---|
| University Hospital, Clermont-Ferrand | OTHER |
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Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis (PD) often have pathophysiological factors that promote chronic constipation. It affects the quality of life of Patients undergoing PD in a much greater way than for hemodialysis patients because it causes complications, mechanical and infectious associated with the transmural migration of enteral bacteria, with an impact on patient morbidity and survival of the technique. In addition, it should be noted that PD patients often take potentially constipants treatments such as phosphorus chelators, calcium inhibitors, opiates, iron preparation and antidepressants. Taking these drugs decreases gastric acidity, which is associated with an increased prevalence of peritonitis.
In this context, a significant lack of literature, specifically studying the risk factors for constipation in Terminal Chronic Kidney Disease patients treated with DP and the correlation with mechanical and infectious complications, is improvable.
Patients included in this trial will be monitored as part of the usual management of their pathology, a Terminal Chronic Kidney Disease treated by the Peritoneal Dialysis technique.
During this treatment, patients will be follow every 2 months in consultation in the Metabolic Diseases Department of the Hospital of Vichy.
These consultations include:
In this prospective trial, there is no intervention on the patient; They will only have to complete questionnaires on their intestinal transit (Charlson Scale, Katz Scale, Neurological Functional Score, Intestinal Function Index, Severity Score for constipation, Bristol Scale, Constipation Assessment Scale, Constipation Risk Assessment Scale). No minimal risk and constraint is identified, excluding our trial from the category of interventional research. The category 3 (non-interventional trial) of the jardé classification is therefore accepted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients | Patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis for at least three months in stable condition |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaires | Other | Patients have to complete the study questionnaires every 2 months :
|
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether there is a relationship between transit disorders and the rate of digestive germ peritonitis in patients with Terminal Chronic Kidney disease on Peritoneal Dialysis | The investigators will count the number of peritonitis associated with transit disorders in patients with Terminal Chronic Kidney Disease undergoing Peritoneal Dialysis | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| To determine whether there are variations in the relationship between transit disorders and the rate of peritonitis depending on the therapeutic management of these transit disorders. | To assess the existence of an episode of peritonitis from all causes | 4 years |
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Inclusion Criteria:
Exclusion Criteria:
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Clinically stable patients who have been in Peritoneal Dialysis for at least three months will be pre-selected three months before the start of the study and included via the Metabolic diseases Center of the Hospital.
This protocol will be offered to adult patients suffering from Terminal Chronic Kidney disease undergoing Peritoneal Dialysis.
The investigator will inform the details of the protocol and answer all questions from patients. It will be given sufficient time to reflect for the signing of the information and non-opposition form. Volunteers will be included after signing this document.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Delphine ROUX | Contact | 0033470971314 | delphine.roux@ch-vichy.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital center | Recruiting | Vichy | 03200 | France |
Source documents defined as any original document or object to prove the existence or accuracy of a data or fact recorded during the clinical study will be kept for 15 years by the Hospital Center; this is the hospital medical record, original results of the patient's biological examinations.
The protocol data that will be collected in the observation book and which will be considered source data can be found in the attached observation book.
Source data will be collected by the service's investigators and nurses; It will be collected in the CRF by investigators.
The data will then be entered into the Excel database by the clinical research officer and a team member (investigator, intern or IDE) for a double entry.
During or after the research, data collected on the appropriate individuals and transmitted to the sponsor by investigators will be anonymized.
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| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
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| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |