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

Polyethylene Glycol Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817788
• Other study ID #: 130022
• Status: Completed
• Phase: Phase 4
• Start date: April 26, 2019
• Est. completion date: April 12, 2020

Study information

• Verified date: April 2020
• Source: Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 586
• Est. completion date: April 12, 2020
• Est. primary completion date: April 2, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Polyethylene Glycol
• Sodium Phosphate

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	the First Hospital of Jilin University	Chang chun	Jilin

Sponsors (2)

Lead Sponsor	Collaborator
Dong Yang	Xu Hong

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cleansing quality	The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.	during the procedure of colonoscopy
Secondary	the duration of the procedure	time to cecal intubation and withdrawal time	during the procedure of colonoscopy
Secondary	patient tolerance	patient tolerance about oral laxatives.	before the procedure of colonoscopy
Secondary	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
Secondary	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
Secondary	patient pain	(visual analog scale, 0-10).	at the end of the procedure of colonoscopy