Observing bowel cleansing effects in patients with renal impairment
Clinical Registry of Adverse Effects in the Preparation for Colonoscopy in Patients With Advanced Renal Failure
Parc de Salut Mar · NCT05349851
This study is trying to see how bowel preparation for colonoscopy affects kidney function in patients with advanced kidney failure, especially those on dialysis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 237 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Parc de Salut Mar (other) |
| Locations | 2 sites (Manresa, Cataluña and 1 other locations) |
| Trial ID | NCT05349851 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a clinical registry to assess the renal adverse effects associated with bowel preparation for colonoscopy in patients with advanced renal failure. It will involve collecting data on kidney function, bowel-cleansing efficacy, and patient tolerability during routine clinical practice. The study will include outpatients scheduled for colonoscopy and will analyze the incidence of renal adverse effects, particularly in those undergoing hemodialysis or peritoneal dialysis. A sample size of 237 subjects will be targeted to ensure robust findings.
Who should consider this trial
Good fit: Ideal candidates are outpatients aged 18-80 with moderate to severe renal impairment scheduled for a colonoscopy.
Not a fit: Patients with conditions such as severe constipation, active intestinal disease, or those who have undergone partial or total colectomy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the safety and tolerability of bowel cleansing procedures in patients with renal impairment.
How similar studies have performed: While bowel preparation in renal impairment has been considered safe, this study is novel in its prospective assessment of renal adverse effects in routine clinical practice.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * Age less than 18 years or greater than 80 years * Partial or total colectomy * Severe constipation * Active inflammatory bowel disease * Severe hepatic impairment (Child Pugh Classification C) * Pregnancy or breastfeeding * Refusal to authorize the clinical registration of the information
Where this trial is running
Manresa, Cataluña and 1 other locations
- Althaia Xarxa Assistencial Universitària de Manresa — Manresa, Cataluña, Spain (RECRUITING)
- Hospital Reina Sofía — Tudela, Navarra, Spain (RECRUITING)
Study contacts
- Principal investigator: Marco A Álvarez, MD, PhD — Althaia Xarxa Assistencial Universitària de Manresa; Institut Hospital del Mar d'investigacions mèdiques, Barcelona.
- Study coordinator: Marco A Álvarez, MD, PhD
- Email: maalvarez@althaia.cat
- Phone: 0034 933160595
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Impairment, Adverse Effects of Medical Drugs, Colonoscopy, Bowel cleansing, Renal impairment, Hydroelectrolytic adverse effects