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FFI and PR Could Improve Bowel Cleansing.

Face-to-face Instructions and Personalized Bowel Cleansing Regimens for Inpatients Could Improve Bowel Preparation Quality.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04605432
Enrollment
320
Registered
2020-10-28
Start date
2020-10-30
Completion date
2021-10-27
Last updated
2021-11-01

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

Conditions

Bowel Preparation

Keywords

bowel preparation; face-to-face instruction; personalized intervention

Brief summary

background:The use of enhanced instruction can improve the efficiency of education for bowel preparation regimens. Researchers hypothesized that face-to-face instruction and personalized intervention for inpatient could improve successful bowel preparation rate and patient's compliance with regimens. Methods:This was an endoscopist-blind,randomized controlled trial. 320inpatients were randomized 1:1 in one of the two study groups. The intervention group received face-to-face instruction and personalized intervention for bowel preparation protocol, while control group received the standard bowel preparation protocol. Patients'demographics, bowel preparation quality, colonoscopy completion and attendance were recorded. Logistic regression was performed to identify predictors of bowel preparation failure.

Interventions

DRUGPEG-FFI

Patients with risk factor : on the day before the colonoscopy at 20:00- 21:00 hours, 60gPEG-4000 was mixed with 1L water; 4-6 h before colonoscopy, 120gPEG-4000 was mixed with 2L water. Patient without risk factor: 4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by experienced researcher.

DRUGPEG-nonFFI

All patients on the day of the colonoscopy:4-6 hours before colonoscopy, 120gPEG-4000 was mixed with 3L water. Education completed by ward nurse.

Sponsors

Ningbo No. 1 Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Inpatients undergoing colonoscopy. * patients older than 18 years.

Exclusion criteria

* prior surgery of colorectal resection; * suspected colonic stricture or perforation; * incomplete or complete bowel obstruction; * use of prokinetic agents or purgatives within 7 days; * Patients with severe gastrointestinal diseases, such as intestinal obstruction or perforation, active ulcerative colitis, toxic colitis and toxic megacolon;; * pregnancy or lactation; * Inability to prepare bowel; * unable to give informed consent.

Design outcomes

Primary

MeasureTime frameDescription
Quality of Bowel Preparation1 Day of colonoscopyThe BBPS is a validated scoring system with scores between 0 and 9, where 9 is the best score. The score comprises a sub score 0-3 for each colon segment: right, transverse and left colon. For all participants, BBPS score will be used when colonscopy is withdrawing.

Secondary

MeasureTime frameDescription
adverse eventsThe day of colonoscopy and the day beforeIncluding nausea, vomiting, abdominal pain and bloating,etc.
cecal intubation rate1 Day of colonoscopyThe number of colonoscopy reaching the cecal area divided by the total number of colonoscopy
polyp detection rate1 Day of colonoscopyPDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients
cecal intubation time1 Day of colonoscopyTime to reach the cecal
withdrawal time1 Day of colonoscopyTime from withdrawal from the cecum to the end of colonoscopy

Countries

China

Outcome results

None listed

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