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OpenTrials
Completed

NCT Number: NCT04605432

FFI and PR Could Improve Bowel Cleansing.

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.

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Key information

Conditions

Bowel Preparation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo No. 1 Hospital

Ningbo, Zhejiang, 315000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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-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.

Primary outcomes

  1. Quality of Bowel Preparation

    Time frame: 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 outcomes

  1. adverse events

    Time frame: The day of colonoscopy and the day before

    Including nausea, vomiting, abdominal pain and bloating,etc.

  2. cecal intubation rate

    Time frame: 1 Day of colonoscopy

    The number of colonoscopy reaching the cecal area divided by the total number of colonoscopy

  3. polyp detection rate

    Time frame: 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

  4. cecal intubation time

    Time frame: 1 Day of colonoscopy

    Time to reach the cecal

  5. withdrawal time

    Time frame: 1 Day of colonoscopy

    Time from withdrawal from the cecum to the end of colonoscopy

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Oct 28, 2020
Registry last updated
Nov 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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