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Completed

NCT Number: NCT03817788

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

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

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Key information

Conditions

Polyethylene Glycol Sodium Phosphate

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

the First Hospital of Jilin University

Changchun, Jilin, 130021, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Polyethylene glycol

Drug

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

Drug

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Dong Yang

Other

Collaborators

  • Xu Hong

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 25, 2019
Registry last updated
Apr 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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