1L- vs. 4L-PEG for Bowel Preparation Among Inpatients.

Colonoscopy Clinical Trial

Official title:

1L- vs. 4L-Polyethylene Glycol for Bowel Preparation Before Colonoscopy Among Inpatients: a Propensity Score-matching Analysis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04310332
• Other study ID #: QIPS propensity score matching
• Status: Completed
• Start date: February 1, 2019
• Est. completion date: December 15, 2019

Study information

• Verified date: March 2020
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background and aims: Inpatients are at high risk for inadequate colon cleansing. Experts recommend 4L-polyethylene-glycol (PEG) solution because of its effectiveness and safety profile. A higher colon cleansing adequacy rate for a hyperosmolar 1L-PEG plus ascorbate prep has been recently reported in an observational study among more than 1,000 inpatients. Thus, the present study is aimed at determining whether 1L-PEG outperforms 4L-PEG among inpatients, through a propensity score-matching between the two groups in order to correct for confounders.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1004
• Est. completion date: December 15, 2019
• Est. primary completion date: December 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult inpatients scheduled for colonoscopy for any indication within the normal process of care.

Exclusion Criteria:

• patients who underwent emergency or elective therapeutic colonoscopies (e.g. polypectomy, endoscopic mucosal resection, endoscopic submucosal dissection)

• patients who underwent bowel preparation outside the hospital

Related Conditions & MeSH terms

• Bowel Preparation
• Colonoscopy
• Hospitalized Patients

Intervention

Drug:
• 1L-PEG
The drug is 1L-PEG plus ascorbic acid (Plenvu®). It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.
• 4L-PEG
The drug is 4L-PEG. It will be administered either the day before colonoscopy, or half the day before and half the day of colonoscopy, or the day of colonoscopy. Patients are prescribed bowel prep according to local clinical practice and then all undergo colonoscopy. No standardized intervention on bowel prep is applied, as the design of the study is observational.

Locations

Country	Name	City	State
Italy	Policlinico Sant'Orsola-Malpighi	Bologna
Italy	Digestive Endoscopy Unit, Fondazione Poliambulanza	Brescia
Italy	UOSD Gastroenterologia ed Endoscopia Digestiva, Azienda USL di Modena	Carpi
Italy	Gastroenterology Unit, Valduce Hospital	Como
Italy	Unit of Gastroenterology and Digestive Endoscopy, Forli-Cesena Hospital, AUSL Romagna	Forlì
Italy	Digestive Endoscopy Unit, Centro Traumatologico-Ortopedico Hospital	Iglesias
Italy	Department of Gastroenterology, ASST Rhodense, Rho and Garbagnate Milanese Hospital	Milan
Italy	Gastroenterology and Digestive Endoscopy Unit, Ospedale Maggiore della Carità	Novara
Italy	Department of Internal Medicine, Gastroenterology and Hepatology Unit, "Guglielmo da Saliceto" Hospital	Piacenza
Italy	Gastroenterology Unit, S. Maria delle Croci Hospital	Ravenna

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall colon cleansing efficacy	Proportion of patients with adequate colon cleansing (Boston Bowel Preparation Score =2 for each colon segment)	Outcome will be assessed during colonoscopy
Primary	Right colon cleansing efficacy	Proportion of patients with adequate colon cleansing in the right colon (Boston Bowel Preparation Score =2 in the right colon)	Outcome is assessed during colonoscopy
Secondary	Safety (serum sodium imbalance)	Degree of serum sodium shift (mmol/L) before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (serum potassium imbalance)	Degree of serum potassium shift (mmol/L) before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (serum calcium imbalance)	Degree of serum calcium shift (mg/dL) before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (serum magnesium imbalance)	Degree of serum magnesium shift (mg/dL) before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (serum creatinine imbalance)	Degree of serum creatinine shift (mg/dL) before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (glomerular filtration rate change)	Degree of change in glomerular filtration rate (mL/min/1.73 m2), before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy
Secondary	Safety (hematocrit change)	Degree of change in hematocrit (%), before and after bowel preparation	within 12 hours before starting bowel prep intake; the morning of the day after the colonoscopy