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

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

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

Conditions
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Polyethylene Glycol, Sodium Phosphate

Intervention / Treatment
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* Drug: polyethylene glycol
* Drug: sodium phosphate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: polyethylene glycol group (group P)<br>For all patients of this group, polyethylene glycol solution should be taken orally for colonic cleansing of colonoscopy | Drug: polyethylene glycol<br>* 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.<br>|
| Experimental: sodium phosphate group (group S)<br>For all patients of this group, sodium phosphate solution should be taken orally for colonic cleansing of colonoscopy | Drug: sodium phosphate<br>* 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.<br>|

What is the study measuring?
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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 |