NCT05349851

Bowel Cleansing With Renal Impairment

Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 237 (estimated)
• Sponsor: Marco Antonio Alvarez Gonzalez · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Renal Impairment
• Adverse Effects of Medical Drugs

Interventions

Type	Name	Description
OTHER	Follow-up with blood and urine analysis	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.

Timeline

• Start date: 2021-10-05
• Primary completion: 2024-01-31
• Completion: 2024-03-31
• First posted: 2022-04-27
• Last updated: 2023-11-18

Locations

2 sites across 1 country: Spain