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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817788
Recruitment Status : Completed
First Posted : January 25, 2019
Last Update Posted : April 17, 2020
Sponsor:
Collaborator:
Xu Hong
Information provided by (Responsible Party):
Dong Yang, Jilin University

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

Condition or disease Intervention/treatment Phase
Polyethylene Glycol Sodium Phosphate Drug: polyethylene glycol Drug: sodium phosphate Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 586 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Randomized Controlled Trail of Polyethylene Glycol vs Sodium Phosphate for Colonic Cleansing of Colonoscopy
Actual Study Start Date : April 26, 2019
Actual Primary Completion Date : April 2, 2020
Actual Study Completion Date : April 12, 2020


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.




Primary Outcome Measures :
  1. Cleansing quality [ Time Frame: during the procedure of colonoscopy ]
    The quality of colon cleansing was assessed by the endoscopist with Boston bowel preparation scale.


Secondary Outcome Measures :
  1. the duration of the procedure [ Time Frame: during the procedure of colonoscopy ]
    time to cecal intubation and withdrawal time

  2. patient tolerance [ Time Frame: before the procedure of colonoscopy ]
    patient tolerance about oral laxatives.

  3. the degree of difficulty of the procedure [ Time Frame: at the end of the procedure of colonoscopy ]
    6-point scale: extremely easy, easy, fairly easy, fairly difficult, difficult, extremely difficult

  4. polyps or other endoscopic lesions [ Time Frame: at the end of the procedure of colonoscopy ]
    For polyps or other endoscopic lesions, a histopathologic diagnosis was systematically obtained and recorded

  5. patient pain [ Time Frame: at the end of the procedure of colonoscopy ]
    (visual analog scale, 0-10).



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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817788


Locations
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China, Jilin
the First Hospital of Jilin University
Chang chun, Jilin, China, 130021
Sponsors and Collaborators
Dong Yang
Xu Hong
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Responsible Party: Dong Yang, Doctor, Jilin University
ClinicalTrials.gov Identifier: NCT03817788    
Other Study ID Numbers: 130022
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: April 17, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No