Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model

Colonoscopy Clinical Trial

Official title:

Efficacy of Tailored Bowel Preparation Strategy Guided by a Predictive Model: a Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03142854
• Other study ID #: 2017SDU-QILU-01
• Status: Completed
• Phase: N/A
• First received: May 3, 2017
• Last updated: September 7, 2017
• Start date: May 1, 2017
• Est. completion date: August 30, 2017

Study information

• Verified date: September 2017
• Source: Shandong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

About 30% of patients were reported to suffer inadequate bowel preparation. So, it is desirable to prescribe personalized regimen according to patient's personal characteristics.

Description:

Colonoscopy is currently the main approach for detecting mucosal abnormalities in the whole colon. Inadequate bowel preparation is the predominant threaten to the efficacy of colonoscopy.Unfortunately, about 30% of patients were reported to suffer inadequate bowel preparation. In order to improve adequate bowel preparation rate, it is desirable to prescribe personalized regimen according to patient characteristics. We intend to create and verify a predictive model for inadequate bowel preparation. Then, in order to improve adequate bowel preparation rate, we aim to establish a bowel preparation strategy guided by the predicted model and verify it.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 429
• Est. completion date: August 30, 2017
• Est. primary completion date: July 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients aged 18 or older

• patients undergoing colonoscopy

Exclusion Criteria:

• patients with a history of colorectal surgery

• patients with severe colonic stricture or obstructing tumor

• patients with dysphagia

• patients with compromised swallowing reflex or mental status

• patients with significant gastroparesis or gastric outlet obstruction

• patients with known or suspected bowel obstruction or perforation

• patients with severe chronic renal failure (creatinine clearance<30 ml/min)

• patients with severe chronic renal failure (creatinine clearance<30 ml/min)

• patients with uncontrolled hypertension (systolic blood pressure>170 mm Hg, diastolic blood pressure>100 mm Hg)

• patients with inflammatory bowel disease or megacolon

• patients with dehydration

• patients with dehydration

• patients with pregnancy or lactation

• patients hemodynamically unstable

• patients unable to give informed consent

Related Conditions & MeSH terms

• Bowel Cleansing Quality
• Colonoscopy

Intervention

Drug:
• Polyethylene Glycol (PEG)
participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.
• Polyethylene Glycol (PEG)
High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen.

Locations

Country	Name	City	State
China	Department of Gastroenterology, Qilu Hospital, Shandong University	Ji'nan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Shandong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	adequate bowel preparation rates between 2 groups.	adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)	4 months