Efficacy of Tailored Bowel Preparation Strategy: A Randomized Controlled Study

NCT03765216 | Unknown DMC

• 1 other identifier: 2018SDU-QILU-09
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

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.

Conditions

Bowel Preparation; Colonoscopy

Outcome Measures

Primary Outcomes (1)

• Adequate bowel preparation rates

  Adequate bowel preparation rates between 2 groups according to Boston Bowel Preparation Scale (BBPS)

  2 months

Secondary Outcomes (1)

• Polyp detection rate

  2 months

Study Arms (2)

Group A: standard group

ACTIVE COMPARATOR

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

Drug: 2L Polyethylene Glycol (PEG)

Group B: tailored group

EXPERIMENTAL

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.

Drug: 2L Polyethylene Glycol (PEG); Drug: 4L Polyethylene Glycol (PEG)

Interventions

2L Polyethylene Glycol (PEG) DRUG

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

Also known as: Standard

Group A: standard group; Group B: tailored group

4L Polyethylene Glycol (PEG) DRUG

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

Also known as: High dose

Group B: tailored group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 18 or older
• patients undergoing colonoscopy

You may not qualify if:

• 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

Sponsors & Collaborators

• Shandong University: lead

Study Sites (1)

Department of Gastroenterology, Qilu Hospital, Shandong University

Ji'nan, Shandong, 250012, China

Location

MeSH Terms

Interventions

Polyethylene Glycols

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Li Yanqing, PhD,MD

  Qilu Hospital of Shandong University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li Yanqing, PhD,MD

CONTACT

86-531-82169236; liyanqing@sdu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice President of Qilu Hospital

Model Details: Participants are randomly assigned to group A or B. Participants of group A are given normal bowel preparation, while participants of group B are given personalized regimens according to a predictive model we have established.

Study Record Dates

• First Submitted: December 4, 2018
• First Posted: December 5, 2018
• Study Start: January 1, 2019
• Primary Completion: February 28, 2019
• Study Completion: March 15, 2019
• Last Updated: December 5, 2018

Record last verified: 2018-12

Locations

CN (1)