Water Exchange and CO2 Insufflation with Abdominal Compression Device to Reduce Manual Assistance

NCT06496958 | Recruiting

• 1 other identifier: EGH-2024
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of this trial is to evaluate whether water exchange colonoscopy and CO2-insufflation colonoscopy with an abdominal compression device (Maxbelt me3 type, Nippon Sigmax Co., Tokyo, Japan) can achieve a significantly lower proportion of patients requiring manual abdominal pressure during colonoscopic insertion compared with CO2 insufflation alone.

Conditions

Manual Pressure; Repositioning; Colonoscopy; Colon Polyp

Outcome Measures

Primary Outcomes (1)

• Frequency of manual pressure

  The proportion of patients who need at least one application of manual abdominal pressure during colonoscopic insertion.

  One day

Secondary Outcomes (7)

• Frequency of repositioning

  One day

• Ergonomic pain of after colonoscopy

  One day

• Colonoscopy difficulty

  One day

• Post-colonoscopy abdominal pain

  One day

• Cecal intubation time

  One day

Study Arms (3)

CO2 insufflation colonoscopy with an abdominal compression device

EXPERIMENTAL

Colonoscopic insertion will be performed with CO2 insufflation with assistance by an abdominal compression device.

Device: CO2 insufflation with an abdominal compression device

CO2 insufflation colonoscopy with a sham abdominal compression device

SHAM COMPARATOR

Colonoscopic insertion will be performed with CO2 insufflation in standard method. A sham abdominal compression device will be used as a sham comparator.

Device: CO2 insufflation with a sham abdominal compression device

Water exchange colonoscopy

ACTIVE COMPARATOR

Colonoscopic insertion will be performed with water exchange method.

Device: Water exchange colonoscopy

Interventions

CO2 insufflation with an abdominal compression device DEVICE

For participants randomized to the intervention group, the back brace support belt, Maxbelt (me3 type, Nippon Sigmax Co., Tokyo, Japan), will be applied around the circumference of the lower abdomen. Five sizes of Maxbelt will be employed in this study. According to the manufacturer, the ultra small-size (XS-size) belt will be used in those patients with an abdominal circumference of 55 cm-65 cm, the small-size (S-size) belt will be used in those patients with an abdominal circumference of 65 cm-75 cm, the medium-size (M-size) belt will be used for a circumference of 75 cm-85 cm, the large-size (L-size) belt will be used for a circumference of 85 cm-95 cm, and the ultra large-size (XL-size) will be used for a circumference of 95 cm-105 cm. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.

CO2 insufflation colonoscopy with an abdominal compression device

CO2 insufflation with a sham abdominal compression device DEVICE

The study coordinator will fit the sham device in a private bay alone with the patient. For participants randomized to the sham control group, a larger-sized Maxbelt with loose fitting will be used as a sham device. The L-size Maxbelt will be used in those patients with an abdominal circumference of 55 cm-71 cm, the XL-size Maxbelt will be used in in those patients with an abdominal circumference of 72 cm-88 cm, and the 2 XL-size Maxbelt will be used in in those patients with abdominal circumference 89 cm-105 cm.

CO2 insufflation colonoscopy with a sham abdominal compression device

Water exchange colonoscopy DEVICE

In those patients assigned to the water exchange (WE) group, the air pump will be turned off during the insertion phase of colonoscopy, while the colon is irrigated with warm-to-touch distilled water or half normal saline using a flushing pump. The WE approach involves the simultaneous infusion of water to facilitate luminal expansion and suction of unclean water during insertion. Any encountered air pockets will be aspirated to ensure optimal WE maneuvers in salvage cleaning.

Water exchange colonoscopy

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged 45-80 years having an average risk for colorectal cancer who plan to undergo sedated outpatient colonoscopy for screening, surveillance, and those who have received a positive fecal immunochemical test result

You may not qualify if:

• Patients with hereditary colorectal cancer syndrome, including familial adenomatous polyposis and hereditary nonpolyposis colorectal cancer (Lynch syndrome)
• Patients with serrated polyposis syndrome
• Patients with known or suspected inflammatory bowel disease
• Patients with a history of colorectal cancer or other intra-abdominal malignancy
• Patients with a history of colorectal resection
• Patients with a history of abdominal aortic aneurysm, cirrhosis, ascites, or other severe comorbid illnesses
• Patients with recent wounds or skin rash on the anterior abdominal wall and back
• Patients with known ventral hernia
• Patients with unsedated procedure
• Patients with planned bidirectional endoscopy
• Patients with body mass index \>35 kg/m2
• Patients with waist circumference \<55 cm or \>105 cm
• Patients with known or suspected gastroparesis
• Patients with planned therapeutic procedures (e.g., hemostasis, removal of a large polyp)
• Patients with mental retardation

Sponsors & Collaborators

• Evergreen General Hospital, Taiwan: lead
• E-Da Dachange Hospital, Kaohsiung, Taiwan: collaborator
• The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA: collaborator

Study Sites (2)

E-Da Dachang Hospital

Kaohsiung City, 807, Taiwan

RECRUITING

Evergreen General Hospital

Taoyuan District, 320, Taiwan

RECRUITING

Related Publications (6)

• Crockett SD, Cirri HO, Kelapure R, Galanko JA, Martin CF, Dellon ES. Use of an Abdominal Compression Device in Colonoscopy: A Randomized, Sham-Controlled Trial. Clin Gastroenterol Hepatol. 2016 Jun;14(6):850-857.e3. doi: 10.1016/j.cgh.2015.12.039. Epub 2016 Jan 6.

  PMID: 26767313 BACKGROUND

• Toyoshima O, Nishizawa T, Sakitani K, Yamakawa T, Yoshida S, Fukagawa K, Hata K, Ishihara S, Suzuki H. Colonoscopy using back brace support belt: A randomized, prospective trial. JGH Open. 2019 Nov 7;4(3):441-445. doi: 10.1002/jgh3.12276. eCollection 2020 Jun.

  PMID: 32514451 BACKGROUND

• Costello B, James T, Hall C, Shergill A, Schlossberg N. Does Manual Abdominal Pressure During Colonoscopy Put Endoscopy Staff and Patients at Risk? Experiences of Endoscopy Nurses and Technicians. Gastroenterol Nurs. 2023 Sep-Oct 01;46(5):386-392. doi: 10.1097/SGA.0000000000000756. Epub 2023 Jun 8.

  PMID: 37289853 BACKGROUND

• Crockett S, Dellon ES, Biggers L, Ernst DA. Use of Patient Abdominal Compression Device Reduces Staff Musculoskeletal Pain Associated With Supporting Colonoscopy: Results From a Randomized Controlled Trial. Gastroenterol Nurs. 2021 Mar-Apr 01;44(2):136-145. doi: 10.1097/SGA.0000000000000550.

  PMID: 33795622 BACKGROUND

• Cadoni S, Falt P, Gallittu P, Liggi M, Mura D, Smajstrla V, Erriu M, Leung FW. Water Exchange Is the Least Painful Colonoscope Insertion Technique and Increases Completion of Unsedated Colonoscopy. Clin Gastroenterol Hepatol. 2015 Nov;13(11):1972-80.e1-3. doi: 10.1016/j.cgh.2015.04.178. Epub 2015 May 5.

  PMID: 25956838 BACKGROUND

• Hsieh YH, Tseng CW, Hu CT, Koo M, Leung FW. Prospective multicenter randomized controlled trial comparing adenoma detection rate in colonoscopy using water exchange, water immersion, and air insufflation. Gastrointest Endosc. 2017 Jul;86(1):192-201. doi: 10.1016/j.gie.2016.12.005. Epub 2016 Dec 15.

  PMID: 27988288 BACKGROUND

MeSH Terms

Conditions

Colonic Polyps

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Chi-Liang Cheng

  Evergreen General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chi-Liang Cheng, MD

CONTACT

+886-919768058; chiliang.cheng@gmail.com

Jen-Hao Yeh, MD

CONTACT

b9202078@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2024
• First Posted: July 11, 2024
• Study Start: September 2, 2024
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)