The Impact of Additional Oral Preparation on the Quality of Bowel Preparation for Colonoscopy

NCT02540031 | Completed Phase 3 DMC

• 1 other identifier: 2015-06-014-003
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

Although adequate bowel preparation is essential for successful colonoscopy, the 23% of patients had shown inadequate bowel preparation. Inadequate bowel preparation may results in incomplete examination, increased patient's discomfort, decreased polyp detection rates, ultimately leading to repeated colonoscopies. One prior study showed that patients reporting their last rectal effluents as brown color or solid stool had a 54% chance of having fair or poor preparation. Thus, recent consensus guideline suggested consideration of additional oral preparation in patients presenting brown effluents on the day of colonoscopy. However, the data supporting additional oral preparation is still spares. Therefore, the investigators aimed to examine the impact of additional oral preparation on the quality of bowel preparation for colonoscopy in patients showing brown effluents on the day of colonoscopy.

Conditions

Bowel Preparation Quality

Outcome Measures

Primary Outcomes (1)

• Quality of bowel preparation

  The primary outcome will be the endoscopist's assessment of the quality of preparation using a standardized bowel preparation scale

  Day 1

Secondary Outcomes (3)

• Adenoma detection rate

  Day 1

• Patient compliance

  Baseline

• Patient satisfaction

  Baseline

Study Arms (2)

Additional oral preparation

EXPERIMENTAL

The investigational or experimental arm will receive standard oral preparation plus additional oral preparation (1l of polyethylene glycol (PEG)+ascorbic acid (Asc)) for colonoscopy. \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Drug: Additional oral preparation (3L of PEG+Asc, "Coolprep®")

Standard oral preparation

ACTIVE COMPARATOR

The control arm will receive currently used oral preparation (2L of polyethylene glycol+ascorbic acid) for colonoscopy. \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Drug: Standard oral preparation (2L of PEG+Asc, "Coolprep®")

Interventions

Additional oral preparation (3L of PEG+Asc, "Coolprep®") DRUG

The interventional or experimental arm will receive 1l of additional PEG+Asc, "Coolprep®" on the day of colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Also known as: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea):3L

Additional oral preparation

Standard oral preparation (2L of PEG+Asc, "Coolprep®") DRUG

The control arm will receive currently used oral preparation (2l of PEG+Asc, "Coolprep®") for colonoscopy \* Compositions/1L : Sodium Chloride 2.691g Potassium Chloride 1.015g Anhydrous sodium sulfate 7.5g PEG 3350 100g ascorbic acid 4.7g sodium ascorbate 5.9g

Also known as: Coolprep® (TaeJoon Pharmaceuticals, Seoul, Korea) : 2L

Standard oral preparation

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who reporting their last rectal effluents as brown color or solid stool on the day colonoscopy

You may not qualify if:

• known hypersensitivity to polyethylene glycol
• severe congestive heart failure \[New York Heart Association (NYHA) grade III or grade IV\]
• severe renal insufficiency (creatinine clearance \<30 ml/min)
• hemodynamic instability
• suspected intestinal obstruction or perforation
• compromised swallowing reflex or altered mental status
• pregnancy or lactating woman
• patients who declined to participate

Sponsors & Collaborators

• Kyungpook National University Hospital: lead

Study Sites (1)

Keimyung University Dongsan Medical Center

Daegu, 700-712, South Korea

Location

Related Publications (1)

• Fatima H, Johnson CS, Rex DK. Patients' description of rectal effluent and quality of bowel preparation at colonoscopy. Gastrointest Endosc. 2010 Jun;71(7):1244-1252.e2. doi: 10.1016/j.gie.2009.11.053. Epub 2010 Apr 1.

  PMID: 20362286 RESULT

Study Officials

• Eun Soo Kim

  Keimyung University Dongsan Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 8, 2015
• First Posted: September 3, 2015
• Study Start: September 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2018-07

Locations

KR (1)