FFI and PR Could Improve Bowel Cleansing.

NCT ID: NCT04605432

Last Updated: 2021-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-30
• Study Completion Date: 2021-10-27

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.

Conditions

Bowel Preparation

Keywords

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PEG-FFI

Intervention Type: DRUG

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 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.

Group Type: ACTIVE_COMPARATOR

PEG-nonFFI

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ningbo No. 1 Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ningbo No. 1 Hospital

Ningbo, Zhejiang, China

Countries

China

Other Identifiers

FFI-1.0

Identifier Type: -

Identifier Source: org_study_id