Dose the Saline Reduce the Mucus Production When Water Exchange Colonoscopy is Used?

NCT04769739 | Completed Results

• 1 other identifier: EGH-2021-2
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to compare the left colon mucus production between carbon dioxide (CO2) insufflation and water exchange (WE) colonoscopy in patients that require a routine or repeat colonoscopy. There will be four arms in this study: CO2 insufflation (control group 1), WE with water infusion (control group 2), WE with 50% saline infusion (study group 1), and WE with 25% saline infusion (study group 2). The patient will prepare himself/herself for the colonoscopy as per normal instructions and he/she will be given the information for the study at that time so that he/she can make a decision to participate in the study. The WE control group will use sterile water filling during colonoscope insertion. The study method will use saline filling during colonoscopy insertion. This study will confirm if using the saline infusion is a better method in reducing mucus production when WE colonoscopy is used.

Conditions

Colon Mucous; Colonoscopy

Keywords

Colonoscopy; Colon Mucus; Water Exchange; Saline

Outcome Measures

Primary Outcomes (1)

• Left Colon Mucus Score

  The amount of residual mucus in the left colon (descending colon, sigmoid colon, rectum) is scaled by a mucus score (5-point scale): score 0: no visible mucus; score 1: minimal amounts of clear mucus in thin streaks or strands; score 2: mild opaque mucus in thin strands; score 3: moderate opaque mucus in thicker clumps covering one side of surface; score 4: more opaque mucus in thicker clumps covering more views of lumen.

  2 hours (data collected during colonoscopy procedure)

Secondary Outcomes (5)

• Adenoma Detection Rate

  one week (data analyzed after the pathology results were available)

• Number of Participants With Cecal Intubation

  2 hours (data collected during colonoscopy procedure)

• Boston Bowel Preparation Scale Score

  2 hours (data collected during colonoscopy procedure)

• Cecal Intubation Time

  2 hours (data collected during colonoscopy procedure)

• Withdrawal Inspection Time

  2 hours (data collected during colonoscopy procedure)

Study Arms (4)

CO2 insufflation

ACTIVE COMPARATOR

Colonoscopy will be performed in the traditional fashion, with minimal insufflation required to aid insertion. Cleaning in the CO2 group will be performed entirely during withdrawal.

Other: CO2

WE with water

ACTIVE COMPARATOR

Residual air in the colon will be removed, water will be infused to guide insertion through an airless lumen. Infused water will be removed by suction, along with residual decal debris, predominantly during insertion.

Other: Water

WE with 50% saline

EXPERIMENTAL

Residual air in the colon will be removed, 50% salline (1:1 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion.

Other: 50% saline

WE with 25% saline

EXPERIMENTAL

Residual air in the colon will be removed, 25% saline (1:3 mixture of saline and water) will be infused to guide insertion through an airless lumen. Infused saline will be removed by suction, along with residual decal debris, predominantly during insertion.

Other: 25% saline

Interventions

CO2 OTHER

using CO2 insufflation to help insertion

CO2 insufflation

Water OTHER

using water instead of traditional gas to help insertion

WE with water

50% saline OTHER

using 50% saline solution instead of traditional gas to help insertion

WE with 50% saline

25% saline OTHER

using 25% saline solution instead of traditional gas to help insertion

WE with 25% saline

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female 20-75 years of age
• Positive screening for Fecal Immunochemical Test (FIT)
• Subjects willing to undergo routine screening and surveillance colonoscopy

You may not qualify if:

• Patients who decline to provide informed consent
• Patients known to have colonic obstruction, active inflammatory bowel disease, or active GI bleeding requiring interventions
• Patients known to have prior history of colonic resection
• Patients with genetic colorectal syndromes
• Patients who are scheduled for therapeutic colonoscopy (e.g., hemostasis, removal of large polyp)
• Patients with American Society of Anesthesiology classification of physical status grade 3 or higher

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead

Study Sites (1)

Evergreen General Hospital

Taoyuan District, 320, Taiwan

Location

Related Publications (4)

• El Rahyel A, McWhinney CD, Parsa N, Lahr RE, Vemulapalli KC, Rex DK. Room temperature water infusion during colonoscopy insertion induces rectosigmoid colon mucus production. Endoscopy. 2020 Dec;52(12):1118-1121. doi: 10.1055/a-1182-5211. Epub 2020 Jun 15.

  PMID: 32458999 BACKGROUND

• Anderson JC, Kahi CJ, Sullivan A, MacPhail M, Garcia J, Rex DK. Comparing adenoma and polyp miss rates for total underwater colonoscopy versus standard CO2: a randomized controlled trial using a tandem colonoscopy approach. Gastrointest Endosc. 2019 Mar;89(3):591-598. doi: 10.1016/j.gie.2018.09.046. Epub 2018 Oct 24.

  PMID: 30367879 BACKGROUND

• Leung FW, Harker JO, Jackson G, Okamoto KE, Behbahani OM, Jamgotchian NJ, Aharonian HS, Guth PH, Mann SK, Leung JW. A proof-of-principle, prospective, randomized, controlled trial demonstrating improved outcomes in scheduled unsedated colonoscopy by the water method. Gastrointest Endosc. 2010 Oct;72(4):693-700. doi: 10.1016/j.gie.2010.05.020. Epub 2010 Jul 8.

  PMID: 20619405 BACKGROUND

• Cheng CL, Kuo YL, Liu NJ, Lien JM, Su IC, Tang CP, Hsieh YH, Leung FW. Randomized Trial Comparing Left Colon Mucus Production Using Water vs Saline During Water Exchange Colonoscopy. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00594. doi: 10.14309/ctg.0000000000000594.

  PMID: 37141104 DERIVED

MeSH Terms

Interventions

Water; Sodium Chloride

Intervention Hierarchy (Ancestors)

Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Sodium Compounds

Results Point of Contact

• Title: Chi-Liang Cheng
• Organization: Evergreen General Hospital

chiliang.cheng@gmail.com

0919768058

Study Officials

• Chiliang Cheng, MD

  Evergreen General Hospital, Taoyuan, Taiwan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2021
• First Posted: February 24, 2021
• Study Start: August 4, 2021
• Primary Completion: March 23, 2022
• Study Completion: April 30, 2022
• Last Updated: January 5, 2024
• Results First Posted: January 5, 2024

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)