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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Outpatients or hospitalized patients with previously scheduled colonoscopy with any indication: screening, follow-up or symptoms.

• Diagnosis of stage 3B-5D chronic renal failure (creatinine clearance less than 45 ml / min / 1.73 m2).

Locations
Other Locations
Spain
Althaia Xarxa Assistencial Universitària de Manresa
RECRUITING
Manresa
Hospital Reina Sofía
RECRUITING
Tudela
Contact Information
Primary
Marco A Álvarez, MD, PhD
maalvarez@althaia.cat
0034 933160595
Backup
Eduardo Albéniz, MD, PhD
ealbenia@navarra.es
0034 848420370
Time Frame
Start Date: 2021-10-05
Estimated Completion Date: 2024-03-31
Participants
Target number of participants: 237
Treatments
Renal failure patiens
Patients with advanced renal failure
Related Therapeutic Areas
Sponsors
Collaborators: Althaia Xarxa Assistencial Universitària de Manresa, Complejo Hospitalario de Navarra
Leads: Marco Antonio Alvarez Gonzalez

This content was sourced from clinicaltrials.gov