Comparison of two different volumes of colonoscopy fluid in hemodialysis patients: randomized non-inferiority study.

Phase 1

• Conditions: Colonoscopy in people receiving hemodialysis; MedDRA version: 20.1Level: HLTClassification code 10053099Term: Gastrointestinal function diagnostic proceduresSystem Organ Class: 100000004848; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05]

• Registration Number: EUCTR2019-004840-30-IT
• Lead Sponsor: Policlinico di Bari-UO Gastroenterologia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-21
• Last Update Posted: 26 July 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 264

Inclusion Criteria

- age =18 years;
- prevalent end stage kidney disease treated with long-term hemodialysis (hemodialysis for at least 6 months; either hemodialysis or hemofiltration or hemodiafiltration, received for at least 3 times/week for a minimum duration of 4 hours per treatment session for a minimum of 12 hours/week, according to standard practice for quality hemodialysis in Italy);
- inpatients and outpatients with an indication to undergo colonoscopy (e.g. positive fecal occult blood test or fecal immunochemical test, signs or symptoms of colorectal disease, colorectal cancer screening, colorectal cancer surveillance, inflammatory bowel diseases, or inclusion in kidney transplantation waiting list);
- signature of written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 264
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 264

Exclusion Criteria

- end stage kidney disease not on hemodialysis (eg. peritoneal dialysis or kidney transplantation);
- previous kidney transplantation;
- need for colonoscopy in emergency;
- previous colorectal surgery;
- contraindications to colonoscopy in the opinion of the managing physician;
- pregnancy or breastfeeding;
- known or suspected hypersensitivity to any components of preparations.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified