Health TrialsbyHealthPanel

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

ConditionsManual PressureRepositioningColonoscopyColon Polyp
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorEvergreen General Hospital, Taiwan

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 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.

  • 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.

Treatment groups

400 Participants
are divided into 3 treatment groups
Group A: CO2 insufflation colonoscopy with an abdominal compression deviceExperimental treatment 1 intervention
Group B: CO2 insufflation colonoscopy with a sham abdominal compression deviceSham comparator 1 intervention
Group C: Water exchange colonoscopyActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Frequency of manual pressure

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

Time frame
One day

Secondary outcomes

1

Frequency of repositioning

The proportion of patients who need at least one application of position change during colonoscopic insertion.

Time frame
One day
2

Ergonomic pain of after colonoscopy

The musculoskeletal pain experienced by the assisting nurse will be reported based on a 5-point visual analogue scale score immediately after a procedure by using a questionnaire.

Time frame
One day
3

Colonoscopy difficulty

The colonoscopy difficulty assessed by the endoscopist will be reported using a 5-point visual analogue scale score immediately after completion of the procedure by using a questionnaire.

Time frame
One day
4

Post-colonoscopy abdominal pain

The pain experienced by the patient will be recorded in the recovery room post-procedure via a questionnaire using a 5-point visual analogue scale score.

Time frame
One day

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Evergreen General Hospital, Taiwan

Lead sponsor

E-Da Dachange Hospital, Kaohsiung, Taiwan

Collaborator

The Sepulveda Ambulatory Care Center, VAGLAHS, UCLA in the USA

Collaborator

Source ClinicalTrials.gov
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