FFI and PR Could Improve Bowel Cleansing.

Sponsor

Ningbo No. 1 Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04605432

Collaborator

(none)

320

Enrollment

Location

Arms

11.9

Actual Duration (Months)

26.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bowel Preparation	Drug: PEG-FFI Drug: PEG-nonFFI	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

320 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Oct 30, 2020

Actual Primary Completion Date :

Jun 30, 2021

Actual Study Completion Date :

Oct 27, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PEG-FFI prep On the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure. The bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Patients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet.	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.
Active Comparator: PEG-nonFFI prep Patients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.	Drug: 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.

Arm

Intervention/Treatment

Experimental: PEG-FFI prep

On the day before colonoscopy, an experienced researcher would go to the ward to have a face-to-face conversation with the patient to know if patients have the risk factors for bowel preparation failure. The bowel preparation regimens for patients with risk factors would be optimized. In addition to drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min, the patient also drink single dose of 60g Polyethylene Glycol (PEG-4000) with 1L water at 20:00- 21:00 hours on the day before the colonoscopy. Patients without risk factors drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min. Patients would received a booklet to explain the details of diet restriction, preparation method and the pictures of bowel preparation of results.The researcher would give a detailed oral explanation of the booklet.

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.

Active Comparator: PEG-nonFFI prep

Patients in the PEG-nonFFI group would only receive routine patient education on bowel preparation of colonoscopy, which was completed by ward nurse. all the patients drink single dose of 120g Polyethylene Glycol (PEG-4000) with 3L water 4-6 h before colonoscopy at a rate of 250 ml every 15 min.

Drug: 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.

Outcome Measures

Primary Outcome Measures

Quality of Bowel Preparation [1 Day of colonoscopy]
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.

Secondary Outcome Measures

adverse events [The day of colonoscopy and the day before]
Including nausea, vomiting, abdominal pain and bloating,etc.
cecal intubation rate [1 Day of colonoscopy]
The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy
polyp detection rate [1 Day of colonoscopy]
PDR was defined as the number of patients with at least one polyp divided by the total number of colonoscopy patients
cecal intubation time [1 Day of colonoscopy]
Time to reach the cecal
withdrawal time [1 Day of colonoscopy]
Time from withdrawal from the cecum to the end of colonoscopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ningbo No. 1 Hospital	Ningbo	Zhejiang	China	315000

Sponsors and Collaborators

Ningbo No. 1 Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ningbo No. 1 Hospital

ClinicalTrials.gov Identifier:

NCT04605432

Other Study ID Numbers:

FFI-1.0

First Posted:

Oct 28, 2020

Last Update Posted:

Nov 1, 2021

Last Verified:

Jan 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Ningbo No. 1 Hospital

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

Study Results

No Results Posted as of Nov 1, 2021