Split-dose Versus Single-dose Bowel Preparation for Colonoscopy

NCT06426745 | Completed DMC

• 1 other identifier: PEG solution
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

Colonoscopy is the current standard method for evaluation of colonic disorders such as colorectal cancer, IBD, polyps, and other conditions.

Conditions

Colonic Cancer; Colonic Polyp; IBS - Irritable Bowel Syndrome

Outcome Measures

Primary Outcomes (1)

• colon cleansing

  to compare the efficacy of split-dose versus single morning administration of PEG solution for colon cleansing in patient undergoing colonoscopy using Boston Bowel Preparation Scale , and to assess the optimal preparation- to-colonoscopy (PC) interval .

  2 hours before Bowel Preparation

Study Arms (2)

Split-dose bowel preparation

EXPERIMENTAL

About 90 participants underwent Split-dose bowel preparation for colonoscopy

Procedure: Bowel preparation

single-dose bowel preparation

EXPERIMENTAL

About 90 participants underwent single-dose bowel preparation for colonoscopy

Procedure: Bowel preparation

Interventions

Bowel preparation PROCEDURE

to compare bowel cleanliness, compliance, tolerability, and patient satisfaction of a single regimen versus a split regimen for colonoscopy.

Also known as: colonoscopy

Split-dose bowel preparation; single-dose bowel preparation

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All patients undergoing elective colonoscopy

You may not qualify if:

• Presence of sever renal impairment. (Creatinine clearance \< 30 ml/min or patient on hemodialysis).
• Sever congestive heart failure (NHYA III or IV).
• Pregnant woman.
• History of bowel obstruction or resection.
• Known allergies to polyethylene glycol.
• Refusal of consent for the study.
• Signs of liver cell failure as ascites and hepatic encephalopathy.
• Electrolytes disturbances

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

Mansoura university Hospital

Al Mansurah, Egypt

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colonic Polyps; Irritable Bowel Syndrome

Interventions

Cathartics; Colonoscopy

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colonic Diseases, Functional

Intervention Hierarchy (Ancestors)

Gastrointestinal Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Seham Mohammad Abd-AlAdl Seif, Professor

  Internal Medicine Hepatology and Gastroenterology Faculty of Medicine - Mansoura University

  STUDY CHAIR

• Hany Shabana, M.D

  Hepatology and Gastroenterology Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2024
• First Posted: May 23, 2024
• Study Start: November 1, 2022
• Primary Completion: October 25, 2023
• Study Completion: December 1, 2023
• Last Updated: May 23, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)