Clinical trial NCT06496958: Water Exchange and CO2 Insufflation with Abdominal Compression Device to Reduce Manual Assistance
Official title: CO2 Insufflation Colonoscopy with an Abdominal Compression Device and Water Exchange Colonoscopy to Reduce Manual Assistance by Endoscopy Staff: a Multicenter Randomized Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Manual Pressure
Repositioning
Colonoscopy
Colon Polyp
Lead sponsor: Evergreen General Hospital, Taiwan
Sponsor class: OTHER
Collaborators: name: E-Da Dachange Hospital, Kaohsiung, Taiwan
name: The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA
First posted: 2024-07-11
Enrollment: 400
Sex: ALL
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Detailed description: This will be a three-arm multicenter parallel randomized controlled trial (RCT) designed to compare the frequency of ancillary manual assistance (abdominal pressure and/or position change) between CO2-insufflation colonoscopy with Maxbelt (intervention group), CO2-insufflation colonoscopy with sham device (sham control group), and water exchange (WE) colonoscopy (WE group). Enrolled patients will be randomized in a 1:1:1 ratio to either the intervention, sham control, or WE group. This will be a comparison of three different methods (CO2 with interventional device, CO2 with sham device, WE) to see which one is better at decreasing the need for manual assistance by endoscopy staff during colonoscopic insertion.

This study will be conducted in two hospitals in Taiwan: Evergreen General Hospital at Taoyuan and E-Da Dachange Hospital at Kaohsiung. The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA will be a non-recruiting participating site. This planned RCT will span 30 months (from June 2024 to November 2026), including 3 months for the initial setup and 3 months for the final analysis. The study site possesses state-of-the-art colonoscopy equipment setups, and the investigators are WE colonoscopy research experts.

Patients aged 45-75 y/o at average risk of colorectal cancer who are willing to participate will sign an informed consent before starting the colonoscopy procedure. Separate parallel randomization will be set up at each site, stratified by investigator and type of colonoscopy (screening, surveillance, or positive fecal immunochemical test result). Mode of sedation will include conscious sedation (fentanyl plus midazolam) or full sedation (propofol with fentanyl plus midazolam) . Randomization will be carried out by computer-generated sequences using a block design (four participants per block).

CO2 with interventional device group: The Maxbelt will be applied around the circumference of the lower abdomen just below the umbilicus based on patient's abdominal circumference. Five sizes of Maxbelt will be employed in this study: XS-size for 55-65 cm circumference, S-size for 65-75 cm circumference, M-size for 75-85 cm circumference, L-size for 85-95 cm circumference, and XL-size for 95-105 cm circumference. Once applied, participants will be asked to assess and confirm that the belt is fastened tightly but not uncomfortably.

CO2 with sham device group: A two-size larger Maxbelt with loose fitting will be used as a sham device: L-size will be used for 55-71 cm circumference, XL-size will be used for 72-88 cm circumference, and 2 XL-size will be used for 89-105 cm circumference.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* Pregnant women or those planning pregnancy
* Patients unwilling to participate in the study

Primary outcomes:
measure: Frequency of manual pressure
timeFrame: One day
Secondary outcomes:
measure: Frequency of repositioning
timeFrame: One day
measure: Ergonomic pain of after colonoscopy
timeFrame: One day
measure: Colonoscopy difficulty
timeFrame: One day
measure: Post-colonoscopy abdominal pain
timeFrame: One day
measure: Cecal intubation time
timeFrame: One day
measure: Withdrawal time
timeFrame: One day
measure: Adenoma detection rate
timeFrame: One week (after the colonoscopy procedure, when pathology report is released)
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: E-Da Dachang Hospital
city: Taoyuan
country: Taiwan
facility: Evergreen General Hospital
Study officials:
affiliation: Evergreen General Hospital
name: Chi-Liang Cheng
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.