Colonoscopy in people receiving hemodialysis MedDRA version: 20.1 Level: HLT Classification code 10053099 Term: Gastrointestinal function diagnostic procedures System Organ Class: 100000004848
Conditions
Interventions
Trade Name: Clensia
Product Name: Clensia
Product Code: [Clensia]
Pharmaceutical Form: Powder for oral solution
INN or Proposed INN: MACROGOL 4000
Current Sponsor code: Clensia
Concentration unit: g g
Sponsors
Policlinico di Bari-UO Gastroenterologia
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study will be to assess the non-inferiority of a low-volume compared with a high-volume polyethylene glycol based bowel preparation for adequate bowel cleansing in people on hemodialysis;Secondary Objective: The secondary objectives will include the comparison of the two cleansing agents on other endoscopic and nephrologic relevant clinical outcomes (adenoma detection rate, cecal intubation rate, participants’ compliance, participants’ tolerability, willingness to repeat the preparation, adverse events, hospitalization, supplementary hemodialysis sessions, hemodialysis performance measures).;Primary end point(s): The primary outcome will be the proportion of participants with adequate bowel cleansing, evaluated using the Boston Bowel Preparation Scale. This standardized tool classifies the quality of bowel preparation for each colonic segment (right, transverse, and left colon) from 0 (very poor) to 3 (excellent), with the total score ranging from 0 to 9.Adequate bowel preparation will be defined as a total score =6 with each segmental score =2.;Timepoint(s) of evaluation of this end point: 13 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - adenoma detection rate, defined as the proportion of participants with one or more adenoma detected during colonoscopy; - cecal intubation rate, defined as the proportion of participants with complete endoscopic examination (i.e. colonoscopy reaching the cecum); - participants’ compliance, defined as the proportion of participants taking =75% of the bowel preparation; - participants’ tolerability, defined as the proportion of participants with gastrointestinal symptoms known to be related to bowel cleansing agents intake (i.e. presence of nausea, bloating, vomiting, abdominal pain, and anal irritation). Each symptom will also be graded as absent, mild, moderate or severe; - participants’ willingness to repeat the preparation, defined as the proportion of participants willing to use the same bowel preparation for future examinations; - adverse events, defined as the proportion of participants experiencing any event occurred during the intake of bowel preparation (e.g. thrombosis of dialysis access, hypo/hypernatremia, hypo/hypercalcemia, hypo/hyperkalaemia, hypo/hyperphosphoremia, muscle cramps, among others); - all-cause hospitalization, defined as the proportion of participants requiring hospitalization for any cause; - all-cause mortality, defined as the proportion of participants dead for any cause; - emergency hemodialysis sessions, defined as the proportion of participants requiring one or more additional hemodialysis sessions; - cardiovascular events, defined as the proportion of participants experiencing cardiovascular complications (i.e. nonfatal myocardial infarction, acute coronary syndrome, or heart failure); - hemodialysis performance measures, including interdialytic body weight gain, variations in serum-electrolyte levels, pre- and post-dialysis systolic blood pressure, pre- and post-dialysis diastolic blood pressure, and blood flow on dialysis.;Timepoint(s) of evaluation of this end point: 13 mesi | — |
Countries
Italy
Contacts
Public ContactUO Gastroenterologia
Policlinico di Bari
Outcome results
None listed