Different Same-day Colonoscopic Bowel Preparation Procedures on Patient Compliance, Tolerability, and Bowel Cleansing

NCT06722209 | Not Yet Recruiting

• 1 other identifier: GSD-3
• Study Type: interventional
• Target: 128
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study was to investigate the effect of different bowel preparation protocols applied on the same day on patients' compliance, tolerance and bowel cleansing before colonoscopy. Hypotheses of the Study : Same-day administration of bowel preparation before colonoscopy; H1.1: There is a significant difference between the bowel preparation protocol with polyethylene glycol (Protocol I) and the protocol with sodium phosphate (Protocol II) in bowel preparation score scores H1.2: There is a significant difference between the compliance levels of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) H1.3: There is a significant difference between the tolerance of the patients who underwent a bowel preparation protocol containing polyethylene glycol (Protocol I) and a protocol containing sodium phosphate (Protocol II) In patients in Protocol I and II groups, data will be collected one day before the procedure with the Descriptive Characteristics Form and the procedure will be explained face to face. After the procedure, bowel preparation score during colonoscopy and compliance and tolerance to the bowel preparation protocol will be evaluated from the patients in both groups.

Conditions

Colonoscopy; Colonoscopy Diagnostic Techniques and Procedures; Colonoscopy Preparation; Colonoscopy Preparation Outcome

Keywords

Colonoscopy; Bowel preparation; Colorectal cancer; Patients compliance

Outcome Measures

Primary Outcomes (1)

• Compliance and Tolerance to the Bowel Preparation Protocol

  The Bowel Preparation Protocol Compliance and Tolerance Assessment Form will assess this primary outcome. This form assesses tolerance to the bowel preparation protocol; abdominal pain, nausea, vomiting, Abdominal distension -gas,thirst , headache, weakness and fatigue and intolerance to the solution. The rate of patients experiencing variables including Compliance and Tolerance to the Bowel Preparation Protocol will be calculated.

  The patients were interviewed 30-60 dk minutes after the procedure was completed.

Secondary Outcomes (1)

• Bowel cleansing quality level

  BBPS will be assessed by the surgeon during colonoscopy.

Study Arms (2)

Experimental: Intervention group

OTHER

Intestinal preparation protocol with polyethylene glycol (Protocol I)

Other: polyethylene glycol (Protocol I)

Control group

OTHER

Intestinal preparation protocol with with sodium phosphate content (protocol II)

Other: polyethylene glycol (Protocol I)

Interventions

polyethylene glycol (Protocol I) OTHER

Intestinal preparation protocol with polyethylene glycol (Protocol I)

Control group; Experimental: Intervention group

Eligibility Criteria

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

You may qualify if:

• Drinking at least 75 per cent of the solution
• Have the ability to read and understand research instructions
• Patients who agreed to participate in the study

You may not qualify if:

• Patients with active lower intestinal bleeding
• KKY
• Liver failure,
• Patients with end-stage acute renal failure

Sponsors & Collaborators

• Eastern Mediterranean University: lead

Related Publications (1)

• Theunissen F, Lantinga MA, Ter Borg PCJ, Ouwendijk RJT, Siersema PD, Bruno MJ; Trans. IT foundation study group. Efficacy of different bowel preparation regimen volumes for colorectal cancer screening and compliance with European Society of Gastrointestinal Endoscopy performance measures. United European Gastroenterol J. 2023 Jun;11(5):448-457. doi: 10.1002/ueg2.12386. Epub 2023 May 15.

  PMID: 37190897 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Polyethylene Glycols

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Intervention Hierarchy (Ancestors)

Ethylene Glycols; Glycols; Alcohols; Organic Chemicals; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Central Study Contacts

GULTEN SUCU DAĞ, Assoc Prof Dr

CONTACT

+905338564904; gulten.dag@emu.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The statistician will not know which group the intervention is for. Data entry will be made as A and B.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Prof

Model Details: prospective randomized controlled trial with experimental and control groups

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 9, 2024
• Study Start: March 1, 2025
• Primary Completion: November 10, 2025
• Study Completion: December 10, 2025
• Last Updated: February 26, 2025

Record last verified: 2025-02