Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte disturbances and volume overload, especially in patients with advanced renal failure. Polyethylene glycol-based regimens are considered safe, even in patients with advanced renal failure. However, the incidence of adverse effects (AEs) in routine clinical practice is unknown. The main objective of this study is to carry out a prospective, observational, multicenter clinical registry of renal AE of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. Variables related to kidney function, bowel-cleansing efficacy, and tolerance will also be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis).
Introduction: Bowel preparation for colonoscopy requires the administration of large amounts of fluids that can cause fluid and electrolyte alterations and volume overload, especially in patients with advanced renal failure. Routine clinical practice of bowel preparation with polyethylene glycol-based regimens, including in patients with advanced renal failure, is considered safe. The hydroelectrolytic AEs and worsening of renal failure are generally mild and transient. However, the incidence of AEs in routine clinical practice is unknown, because there is no prospective record of the incidence of renal AEs in these patients. Objectives: 1. Principal. To carry out a clinical registry of the renal AEs of the preparation for colonoscopy, in patients with advanced renal failure, within the usual clinical practice of the preparation. 2. Secondary: * Study the efficacy of intestinal cleansing using the Boston bowel preparation scale. * Study the patient-reported experience measures (PREMs) in terms of tolerability and acceptance of bowel preparation. Study of the population and sample size: Outpatients with a scheduled colonoscopy for any indication and with moderate or severe renal impairment. Ages: 18-80, excluding partial colectomy, severe constipation, active intestinal disease, severe heart or liver failure, pregnancy or lactation, and refusal to authorize the clinical record of information. We calculated a sample size of 237 subjects to show an incidence of renal AD of 10%, with a precision of 4%. Methods: Identify patients with a scheduled colonoscopy who present advanced renal failure, in the 60 days prior to the colonoscopy. Carry out a prospective, observational, multicenter clinical registry of the routine clinical practice of preparation for colonoscopy. Variables related to renal function, the efficacy of intestinal cleansing, and tolerance will be recorded. A segmented analysis will be performed in patients with substitutive renal therapy (hemodialysis or peritoneal dialysis). The data will be collected on the REDCap-AEG online platform, which can be accessed by researchers from each center through an identification code, respecting the current Organic Law on Data Protection.
Study Type
OBSERVATIONAL
Enrollment
237
The patients will receive the preparation standards according to the usual clinical practice of each center. On the day of the colonoscopy, patient will be informed about this study and the informed consent will be requested to record the study information. Then, an analysis will be carried out. A second visit will be carried out, follow-up at 3-7 days, which will include a clinical interview and an analysis, being the unique intervention that patients receive.
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Catalonia, Spain
RECRUITINGHospital Reina Sofía
Tudela, Navarre, Spain
RECRUITINGGlobal incidence of renal adverse effects (AEs)
Global incidence of renal adverse effects (AEs) (yes/no) if any of the following variables have an abnormal value in serum: sodium, potassium, calcium, chloride, bicarbonate, creatinine, or the glomerular filtrate rate calculated with the MDRD formula and the CKD-EPI formula.
Time frame: 3 hours to 7 days after laxative intake
Serum sodium concentration
Any abnormal value in serum sodium concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum potasium concentration
Any abnormal value in serum potasium concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum ionized calcium concentration
Any abnormal value in serum ionized calcium concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum chloride concentration
Any abnormal value in serum chloride concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum bicarbonate concentration
Any abnormal value in serum bicarbonate concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum creatinine concentration
Any abnormal value in serum creatinine concentration.
Time frame: 3 hours to 7 days after laxative intake
Glomerular filtration rate
Glomerular filtration rate calculated with the MDRD formula and the CKD-EPI formula.
Time frame: 3 hours to 7 days after laxative intake
Serum phosphorus concentration
Any abnormal value in serum phosphorus concentration.
Time frame: 3 hours to 7 days after laxative intake
Serum magnesium concentration
Any abnormal value in serum magnesium concentration.
Time frame: 3 hours to 7 days after laxative intake
Blood pH
Blood pH measurement
Time frame: 3 hours to 7 days after laxative intake
Hemoglobin concentration
Mean corpuscular hemoglobin
Time frame: 3 hours to 7 days after laxative intake
Blood platelets
Number of blood platelets
Time frame: 3 hours to 7 days after laxative intake
Adequate bowel cleansing for colonoscopy
Application of the Boston Bowel Preparation Scale to evaluate colonoscopy bowel cleansing. The efficacy of bowel preparation will be rated by blinded endoscopists using the Boston Bowel Preparation Scale (BBPS). Adequate bowel cleansing will be defined as a BBPS of 2 or more points in every segment of the colon and inadequate bowel cleansing will be defined by at least one of the colon segments with less than 2 points.
Time frame: At the moment of colonoscopy
Adhrence to laxative intake
Adhrence to laxative intake recorded as \>75% of the quantity of laxative intake reported in a questionarie administered with the help of an investigator.
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Time from last intake of laxative to the colonoscopy
Interval in hours between last intake of laxative and the colonoscopy.
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Patient-reported experience measures (PREMs) questionnaire of laxative intake
Patient-reported experience measures (PREMs) questionnaire of laxative intake, administered with the help of an investigator. Descriptive subjective scale: Very bad, bad, average, good, very Good.
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Early side effects of laxative intake
Early side effects of laxative intake. Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating. Non structured for other side effects.
Time frame: 3-5 hours after laxative intake (at the colonoscopy appointment)
Late side effects of laxative intake
Structured questionnaire nausea, vomiting, dizziness, thirst, headache, abdominal bloating, abdominal pain, mental confusion, asthenia, dyspnea, peripheral edema. Non structured for other side effects.
Time frame: 3-7 days after laxative intake
Need of urgent consultation
Number of participants requiring medical consultation for kidney related problems, including emergency room or nephrologist consultation.
Time frame: 3 hours to 7 days after laxative intake
Need for hospital admission
Number of participants requiring hospital admission for any kidney related causes.
Time frame: 3 hours to 7 days after laxative intake
Need of any drug treatment, new treatment or modification, that may affect kidney function or serum electrolytes
Number of participants that require outpatient medication change after the intervention.
Time frame: 3 hours to 7 days after laxative intake
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