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

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

Study Overview

• Status: Completed
• Conditions: Polyethylene Glycol; Sodium Phosphate
• Intervention / Treatment: Drug: polyethylene glycol; Drug: sodium phosphate

• Study Type: Interventional
• Enrollment (Actual): 586
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Jilin
    • Chang chun, Jilin, China, 130021
      • The First Hospital of Jilin University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 1) 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: polyethylene glycol group (group P); For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy	Drug: polyethylene glycol; 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.
EXPERIMENTAL: sodium phosphate group (group S); For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy	Drug: sodium phosphate; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cleansing quality	The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.	during the procedure of colonoscopy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the duration of the procedure	time to cecal intubation and withdrawal time	during the procedure of colonoscopy
patient tolerance	patient tolerance about oral laxatives.	before the procedure of colonoscopy
the degree of difficulty of the procedure	6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult	at the end of the procedure of colonoscopy
polyps or other endoscopic lesions	For polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded	at the end of the procedure of colonoscopy
patient pain	(visual analog scale, 0-10).	at the end of the procedure of colonoscopy

Collaborators and Investigators

• Sponsor: Dong Yang
• Collaborators: Xu Hong

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 26, 2019
• Primary Completion (ACTUAL): April 2, 2020
• Study Completion (ACTUAL): April 12, 2020

Study Registration Dates

• First Submitted: January 23, 2019
• First Submitted That Met QC Criteria: January 23, 2019
• First Posted (ACTUAL): January 25, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 17, 2020
• Last Update Submitted That Met QC Criteria: April 15, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 130022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No