FFI and PR Could Improve Bowel Cleansing.

Bowel Preparation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605432
• Other study ID #: FFI-1.0
• Status: Completed
• Phase: N/A
• Start date: October 30, 2020
• Est. completion date: October 27, 2021

Study information

• Verified date: January 2021
• Source: Ningbo No. 1 Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: October 27, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bowel Preparation

Intervention

Drug:
• PEG-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.
• PEG-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.

Locations

Country	Name	City	State
China	Ningbo No. 1 Hospital	Ningbo	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Ningbo No. 1 Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of Bowel Preparation	The 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.	1 Day of colonoscopy
Secondary	adverse events	Including nausea, vomiting, abdominal pain and bloating,etc.	The day of colonoscopy and the day before
Secondary	cecal intubation rate	The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy	1 Day of colonoscopy
Secondary	polyp detection rate	PDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients	1 Day of colonoscopy
Secondary	cecal intubation time	Time to reach the cecal	1 Day of colonoscopy
Secondary	withdrawal time	Time from withdrawal from the cecum to the end of colonoscopy	1 Day of colonoscopy