NCT06141122

Brief Summary

This study aimed to provide a recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list. In this way, we aimed to minimize confusion regarding dietary restrictions during colonoscopy preparation and ensure full compliance with the diet list. Our hypothesis is that this approach may enhance compliance with current recommendations and improve the quality of bowel preparation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 21, 2023

Completed
Last Updated

November 12, 2024

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 15, 2023

Last Update Submit

November 9, 2024

Conditions

Bowel PreparationPatient ExperiencePatient Satisfaction

Outcome Measures

Primary Outcomes (1)

  • Boston Bowel Preparation Scale (BBPS)

    The BBPS is used to evaluate the quality of bowel preparation, with a scale from 0 to 9 (0 = very poor, 9 = excellent). Total BBPS score ≥ 6 and three segments of the colon (right, transverse, and the left side of the colon) ≥ 2 accepted as good bowel preparation

    immediately after the procedure

Secondary Outcomes (4)

  • cecal insertion time(minutes)

    during the procedure

  • withdrawal time (minutes)

    during the procedure

  • polyp detection rate

    during the procedure

  • patient experience

    immediately after the procedure

Study Arms (2)

The booklet group

EXPERIMENTAL

The research protocol was explained during the colonoscopy appointment, and patients, when they agreed to follow their diet according to the recipe booklet, were accepted as part of the patient intervention group.

Other: A recipe booklet

control

NO INTERVENTION

The control group consists of patients who prepared for colonoscopy with the standard low-residue diet list without being given a recipe booklet.

Interventions

A recipe bookletOTHER

A recipe resource with visuals in line with the low-residue diet recommendations given to patients before colonoscopy, including cooking instructions for the meals in the diet list.

The booklet group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- All outpatients who apply for a colonoscopy appointment.

You may not qualify if:

  • Patients with a history of prior colonoscopic procedures
  • Using anticholinergic or gastrointestinal motility-reducing drugs
  • Severe chronic kidney failure (GFR\<30 ml/min)
  • Advanced heart failure (NYHA III-IV)
  • History of abdominal surgery were not included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abdurrahman Yurtaslan Oncology and Training Research Hospital

Ankara, 06200, Turkey (Türkiye)

Location

Related Publications (3)

  • Bennett L, Knox R, Luscombe G, Egan J, Wallace L. The Colonoscopy Cookbook: Analysis of effect of a recipe resource on quality and experience of bowel preparation in colonoscopy. Endosc Int Open. 2023 May 26;11(5):E561-E565. doi: 10.1055/a-2057-4374. eCollection 2023 May.

    PMID: 37251792BACKGROUND

  • Spiegel BM, Talley J, Shekelle P, Agarwal N, Snyder B, Bolus R, Kurzbard N, Chan M, Ho A, Kaneshiro M, Cordasco K, Cohen H. Development and validation of a novel patient educational booklet to enhance colonoscopy preparation. Am J Gastroenterol. 2011 May;106(5):875-83. doi: 10.1038/ajg.2011.75. Epub 2011 Apr 12.

    PMID: 21483463BACKGROUND

  • Tae JW, Lee JC, Hong SJ, Han JP, Lee YH, Chung JH, Yoon HG, Ko BM, Cho JY, Lee JS, Lee MS. Impact of patient education with cartoon visual aids on the quality of bowel preparation for colonoscopy. Gastrointest Endosc. 2012 Oct;76(4):804-11. doi: 10.1016/j.gie.2012.05.026. Epub 2012 Jul 27.

    PMID: 22840295BACKGROUND

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • selim demirci

    clinical physician

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
All elective colonoscopies were performed by two experienced endoscopists who were unaware of the group assignments.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical physician

Study Record Dates

First Submitted

November 15, 2023

First Posted

November 21, 2023

Study Start

September 15, 2023

Primary Completion

November 1, 2023

Study Completion

November 1, 2023

Last Updated

November 12, 2024

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)