Comparison Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

Study Overview
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Brief Summary
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High quality bowel preparation is essential for successful colonoscopy. This study aimed to assess the impact of the dose of Polyethylene Glycol(PEG) on the quality of bowel preparation. This prospective, endoscopist-blinded, randomized, controlled study was conducted. 3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. 4L-group received 4bags of PEG and were instructed to drink 2 L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. The primary outcome was the quality of the bowel preparation according to the Boston Bowel Preparation Scale (BBPS). The secondary outcomes included polyp detection rate (PDR), adenoma detection rate (ADR), tolerance, and subjective feelings of patients.

Official Title
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Comparison of the Efficacy and Tolerability Between 3-L and 4-L Polyethylene Glycol in Bowel Preparation

Conditions
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Bowel Preparation Scale, Adenoma Detection Rate

Intervention / Treatment
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* Drug: 4L Polyethylene Glycol
* Drug: 3L Polyethylene Glycol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients aged 18-75 years Referred for routine diagnostic colonoscopy Patients who have signed inform consent form Exclusion Criteria: pregnancy or breastfeeding allergy to purgatives suspected intestinal obstruction, stricture, or perforation hemodynamic instability impaired swallowing reflex or mental status severely medical status, such as New York Heart Association grade III or grade IV congestive heart failure and severe renal failure history of oesophagus、stomach 、duodenum、small intestine or colorectal surgery participation declined.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Screening
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4L Polyethylene Glycol<br>4L-group received 4 bags of PEG and were instructed to drink 2L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. | Drug: 4L Polyethylene Glycol<br>* 4L group received double-dose PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes.<br>|
| Active Comparator: 3L Polyethylene Glycol<br>3L-group received 3 bags of PEG and were instructed to drink 1L at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes, and to drink the remaining 2L 4 to 6 h before colonoscopy at the same rate. | Drug: 3L Polyethylene Glycol<br>* 3L group were instructed to drink 1L PEG at 19:00 in the evening before the day of colonoscopy at a rate of 250 mL every 15 minutes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Boston Bowel Preparation Scale | The primary end point of the study was adequate bowel preparation quality de ned as a BBPS total score of ≥6 with all segment scores ≥2 | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp detection rate | The secondary end point of the study included polyp detection rate | 2 days | 
| Adenoma detection rate | The secondary end point of the study included adenoma detection rate | 2 days | 
| The mean number of incremental adenomas | It was a new metric called ADR-Plus, the mean number of incremental adenomas after the fist. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polyp detection rate, Adenoma detection rate, Boston Bowel Preparation Scale