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

Phase 4

Completed

• Conditions: Polyethylene Glycol; Sodium Phosphate
• Interventions: Drug: sodium phosphate; Drug: polyethylene glycol

• Registration Number: NCT03817788
• Lead Sponsor: Dong Yang

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-23
• Study First Submitted QC: 2019-01-23
• Study First Posted: 2019-01-25
• Study Start: 2019-04-26
• Status Verified: 2020-04
• Primary Completion: 2020-04-02
• Study Completion: 2020-04-12
• Last Update Submitted: 2020-04-15
• Last Update Posted: 2020-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 586

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
sodium phosphate group (group S)	sodium phosphate	For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy
polyethylene glycol group (group P)	polyethylene glycol	For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy

Primary Outcome Measures

Name	Time	Method
Cleansing quality	during the procedure of colonoscopy	The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

the First Hospital of Jilin University; 🇨🇳 Chang chun, Jilin, China