FFI and PR Could Improve Bowel Cleansing.

NCT04605432 | Completed

• 1 other identifier: FFI-1.0
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• adverse events

  The day of colonoscopy and the day before

• cecal intubation rate

  1 Day of colonoscopy

• polyp detection rate

  1 Day of colonoscopy

• cecal intubation time

  1 Day of colonoscopy

• withdrawal time

  1 Day of colonoscopy

Study Arms (2)

PEG-FFI prep

EXPERIMENTAL

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

PEG-nonFFI prep

ACTIVE COMPARATOR

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

Interventions

PEG-FFI 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-FFI prep

PEG-nonFFI 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.

PEG-nonFFI prep

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo No. 1 Hospital

Ningbo, Zhejiang, 315000, China

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2020
• First Posted: October 28, 2020
• Study Start: October 30, 2020
• Primary Completion: June 30, 2021
• Study Completion: October 27, 2021
• Last Updated: November 1, 2021

Record last verified: 2021-01

Locations

CN (1)