Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy

NCT03817788 | Completed Phase 4 DMC

• 1 other identifier: 130022
• Study Type: interventional
• Target: 586
• Locations: 1 country
• Sites: 1

Brief Summary

This study is to compare polyethylene glycol and sodium phosphate for colonic cleansing of colonoscopy.

Conditions

Polyethylene Glycol; Sodium Phosphate

Outcome Measures

Primary Outcomes (1)

• Cleansing quality

  The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.

  during the procedure of colonoscopy

Secondary Outcomes (5)

• the duration of the procedure

  during the procedure of colonoscopy

• patient tolerance

  before the procedure of colonoscopy

• the degree of difficulty of the procedure

  at the end of the procedure of colonoscopy

• polyps or other endoscopic lesions

  at the end of the procedure of colonoscopy

• patient pain

  at the end of the procedure of colonoscopy

Study Arms (2)

polyethylene glycol group (group P)

ACTIVE COMPARATOR

For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy

Drug: polyethylene glycol

sodium phosphate group (group S)

EXPERIMENTAL

For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy

Drug: sodium phosphate

Interventions

polyethylene glycol DRUG

All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For polyethylene glycol group (group P): the day before colonoscopy, 750 mL (1 box) of polyethylene glycol solution should be drunk 2 hours after dinner; the other 1500 ml (2 boxes) of polyethylene glycol solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same juniar clinician, and related indicators were recorded.

polyethylene glycol group (group P)

sodium phosphate DRUG

All patients should receive dietary guidance, and eat a low-residue diet three days before colonoscopy. For sodium phosphate group (group S), 750 mL (1 box) of sodium phosphate solution should be drunk 2 hours after dinner; and the other 750 mL (1 box) of sodium phosphate solution should be taken 4-6 hours before the examination. After oral laxatives were finished, 20 ml dimethicone would be taken orally as defoamer. All the enteroscopy should by performed by the same clinician, and related indicators were recorded.

sodium phosphate group (group S)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Outpatients meet the following criteria: 1) age 18-60 years; 2) BMI 18.9-28; 3) Heart, lung, liver, and kidney function can tolerate colonoscopy; 4) Patients and their families are able to understand and be willing to participate in this clinical study and to sign informed consent

You may not qualify if:

• \) colorectal surgery history (except appendectomy); 2) patients with intestinal obstruction, incomplete obstruction, intestinal hemorrhage; 3) patients with renal insufficiency; 4) patients with hirschsprung disease; 5) patients with inflammatory bowel disease during active period, which affects intestinal observation; 6) patients who are bedridden and lose the moving ability ; 7) have a history of severe mental illness; 8) pregnant or lactating women; 9) patients with other clinical conditions considered by some researchers should not participate in the trial.

Sponsors & Collaborators

• Dong Yang: lead
• Xu Hong: collaborator

Study Sites (1)

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Location

MeSH Terms

Interventions

Polyethylene Glycols; sodium phosphate

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: January 23, 2019
• First Posted: January 25, 2019
• Study Start: April 26, 2019
• Primary Completion: April 2, 2020
• Study Completion: April 12, 2020
• Last Updated: April 17, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)