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Comparison of Two Methods for Bowel Preparation in Patients With Constipation

Comparison of Two Split-dose Regimes for Bowel Preparation in Patients With Constipation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03306030
Enrollment
140
Registered
2017-10-10
Start date
2017-09-01
Completion date
2018-11-30
Last updated
2017-11-28

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

Conditions

Health Behavior

Keywords

PEG, Bowel preparation, Colonoscopy, split-does

Brief summary

Constipation is a common high risk factor for inadequate bowel preparation. The bowel cleansing efficacy of the standard split-does of 4L seems to be suboptimal in constipated patients. The investigator hypothesized that compared with the standard preparation regime, the split-dose with three times of 4L PEG may be superior in BP quality.

Interventions

All patients were given oral instruction for bowel preparation on the day of appointment and re-instruction through phone call on two days before scheduled colonoscopy. They were instructed to have a regular lunch and take only clear liquid or low-residual food for the dinner on the day before colonoscopy. The participants began to drink the first 2 L of PEG at 7:00-9 PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients took the remaining 2 L 4-6 hours before colonoscopy.

DRUGThree times dose of 4L PEG

The same as mentioned above. The participants began to drink the first 1.5 L of PEG at 2:00 PM and the second 1.5L of PEG at 8:00PM on the day before colonoscopy at a rate of 250 mL every 15 minutes. On the day of the procedure, patients take the remaining 1.0 L 4-6 hours before colonoscopy.

Sponsors

Air Force Military Medical University, China
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Patients aged 18-80 with constipation.

Exclusion criteria

* History of colorectal surgery BMI\>30 Suspected colonic stricture or bowel obstruction Use of purgatives within 3 days Pregnancy or lactation Unable to give informed consent Haemodynamically unstable

Design outcomes

Primary

MeasureTime frameDescription
Rate of adequate bowel preparation1 yearAdequacy of bowel preparation quality was defined as a total score ≥6 and each segmental score ≥2. The total scores included 3 scores of colonic regions: the right side, the transverse section, and the left side, which ranged from 0 to 9 (0= very poor, 9=excellent). For the unreached colon in incomplete colonoscopy, the segmental BBPS was scored as 0. The total and segmental scores were judged through videos by investigators who were familiar with the criteria and blinded to group allocation.

Secondary

MeasureTime frame
Adverse event rate1 year
Cecal intubation rate1 year
Cecal intubation time1 year
Withdrawal time1 year
Polyps detection rate1 year

Countries

China

Contacts

Primary ContactHui Jia
jiahuifmmu@163.com+862984771536

Outcome results

None listed

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