Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

NCT ID: NCT03765216

Last Updated: 2018-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2019-03-15

Brief 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.

Detailed 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 improve adequate bowel preparation rate by deploying tailored bowel preparation strategy. There are many predictive factors of inadequate bowel preparation such as obesity, constipation, abdominal surgery and so on. By recognizing these risk factors of the patients , we can prescribe the patients with higher dose of bowel cleansing regimen to improve bowel preparation quality.

Conditions

Bowel Preparation; Colonoscopy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Group A: standard group

Participants are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen.

Group Type: ACTIVE_COMPARATOR

2L Polyethylene Glycol (PEG)

Intervention Type: DRUG

Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen

Group B: tailored group

Participants are given personalized regimens for bowel preparation according to the the predictive model( a model which grades patients as low or high risk according to risk factors such as age, body mass index≧ 30 kg/m2, diabetes, constipation, pelvic surgery and tricyclic antidepressants usage).

Low risk patients are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen; High risk patients are given standard regimen: 4 L Polyethylene Glycol (PEG) regimen.

Group Type: EXPERIMENTAL

2L Polyethylene Glycol (PEG)

Intervention Type: DRUG

Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen

4L Polyethylene Glycol (PEG)

Intervention Type: DRUG

High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen

Interventions

2L Polyethylene Glycol (PEG)

Participants in Group A and Low risk patients in group B are given standard regimen: 2 L Polyethylene Glycol (PEG) regimen

Intervention Type: DRUG

4L Polyethylene Glycol (PEG)

High risk patients in Group B will receive 4 L Polyethylene Glycol (PEG) regimen

Intervention Type: DRUG

Other Intervention Names

Standard; High dose

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Yanqing Li

Vice President of Qilu Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Li Yanqing, PhD,MD

Role: PRINCIPAL_INVESTIGATOR

Qilu Hospital, Shandong University

Locations

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, China

Countries

China

Central Contacts

Li Yanqing, PhD,MD

Role: CONTACT

liyanqing@sdu.edu.cn

86-531-82169236

Other Identifiers

2018SDU-QILU-09

Identifier Type: -

Identifier Source: org_study_id