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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03817788
Enrollment
586
Registered
2019-01-25
Start date
2019-04-26
Completion date
2020-04-12
Last updated
2020-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polyethylene Glycol, Sodium Phosphate

Brief summary

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

Interventions

DRUGpolyethylene 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.

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.

Sponsors

Xu Hong
CollaboratorUNKNOWN
Dong Yang
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Cleansing qualityduring the procedure of colonoscopyThe quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.

Secondary

MeasureTime frameDescription
the duration of the procedureduring the procedure of colonoscopytime to cecal intubation and withdrawal time
patient tolerancebefore the procedure of colonoscopypatient tolerance about oral laxatives.
the degree of difficulty of the procedureat the end of the procedure of colonoscopy6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult
polyps or other endoscopic lesionsat the end of the procedure of colonoscopyFor polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded
patient painat the end of the procedure of colonoscopy(visual analog scale, 0-10).

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026