Cap-Assisted Colonoscopy for Reduced Pain and Insertion Time

(VA Trial)

Recruiting at 1 trial location

Overseen By Felix W Leung, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Greater Los Angeles Healthcare System

Must not be taking: Narcotics, Anxiolytics, Anticoagulants

Disqualifiers: Colon surgery, Inflammatory bowel disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

256 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new method for colonoscopy that uses water and a small cap to make the procedure less painful and more effective for veterans. The water method for colonoscopy, which involves water infusion instead of air, has been shown to reduce patient discomfort and sedation requirements in several studies.

Will I have to stop taking my current medications?

The trial excludes participants who are currently using narcotic or anxiolytic medications (drugs for pain relief or anxiety), so you would need to stop these medications to participate. It also excludes those on anticoagulant therapy (blood thinners).

What data supports the effectiveness of the treatment Water Exchange (WE) Plus Cap-assisted Colonoscopy?

Research shows that the Water Exchange (WE) method can reduce discomfort during colonoscopy and improve the detection of adenomas (a type of polyp that can develop into cancer). Cap-assisted colonoscopy helps to reduce the time it takes to reach the cecum (the beginning of the large intestine), making the procedure quicker and potentially more comfortable. ^{1 2 3 4 5}

Is cap-assisted colonoscopy with water exchange safe for humans?

The studies suggest that water exchange colonoscopy, including cap-assisted versions, is generally safe for humans, as it reduces pain and discomfort during the procedure. However, it may require longer procedure times due to the need to remove infused water and residual air. ^{1 2 3 4 6}

How does the treatment Water Exchange Plus Cap-assisted Colonoscopy differ from other treatments for colonoscopy?

This treatment combines water exchange, which reduces pain and improves adenoma detection, with cap-assisted colonoscopy, which shortens the time needed to reach the cecum (the beginning of the large intestine). This combination aims to reduce discomfort and procedure time compared to traditional methods that use air or carbon dioxide to inflate the colon. ^{1 2 5 7 8}

Research Team

Felix W Leung, MD

Principal Investigator

VA Greater Los Angeles Healthcare System

Eligibility Criteria

This trial is for male and female Veterans who opt for unsedated colonoscopy, whether it's for screening, diagnosis, or surveillance. Participants must be able to consent and complete questionnaires. Those with a history of certain abdominal surgeries, current heavy medication use, or conditions that complicate colonoscopy are excluded.

Inclusion Criteria

Informed/educated male and female Veterans undergoing screening, diagnostic or surveillance colonoscopy at participating sites, choosing scheduled unsedated colonoscopy for any reason

Exclusion Criteria

Request of on demand sedation

You have an artificial heart valve.

You have a medical condition that could make colonoscopy risky for you.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo colonoscopy using either the WE or WECAC method to assess pain and insertion time

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the colonoscopy procedure

2 weeks

Treatment Details

Interventions

• Water Exchange (WE)
• WE Plus Cap-assisted Colonoscopy

Trial Overview The study compares two methods during a colonoscopy: the Water Exchange (WE) method alone versus WE plus Cap-assisted Colonoscopy (WECAC). The goal is to see if adding a cap reduces pain more than WE alone and if it improves the procedure time and detection rate of adenomas in the proximal colon.

Participant Groups

Group I: WE plus cap(WECAC) Experimental Treatment 2 Interventions

The procedure of this group is similar with WE group, except a cap will be fitted onto the end of the colonoscope.

Group II: Water exchange (WE) Active Control 1 Intervention

This group will have the air in the colon removed and replaced with water to guide the insertion of the colonoscope.

Who Is Running the Clinical Trial?

VA Greater Los Angeles Healthcare System

Lead Sponsor

Trials

53

Recruited

8,700+

VA Palo Alto Health Care System

Collaborator

Trials

97

Recruited

58,500+

VA Northern California Health Care System

Collaborator

Trials

19

Recruited

3,400+

References

1. England pubmed.ncbi.nlm.nih.gov

Cecal intubation time between cap-assisted water exchange and water exchange colonoscopy: a randomized-controlled trial. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Impact of water exchange colonoscopy on endoscopy room efficiency: a systematic review and meta-analysis. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Editorial: Polyps, Pain, and Propofol: Is Water Exchange the Panacea for All? [2023]

4. India pubmed.ncbi.nlm.nih.gov

Is water exchange superior to water immersion for colonoscopy? A systematic review and meta-analysis. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

A novel method with significant impact on adenoma detection: combined water-exchange and cap-assisted colonoscopy. [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Cecal intubation time between the use of one-channel and two-channel water exchange colonoscopy: A randomized controlled trial. [2020]

7. Korea (South) pubmed.ncbi.nlm.nih.gov

Painless Colonoscopy: Available Techniques and Instruments. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Water-Assisted Colonoscopy. [2022]