Cap-Assisted Colonoscopy for Reduced Pain and Insertion Time

(VA Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to make colonoscopies less painful and quicker. Researchers compare two techniques: the traditional water exchange (WE) method and an experimental approach that adds a cap to the colonoscope, known as WE plus cap (WECAC). The goal is to determine if the WECAC method reduces discomfort and speeds up the process while possibly detecting more issues in the colon. Veterans scheduled for a colonoscopy without sedation might be a good fit for this trial. As an unphased trial, this study offers veterans the chance to contribute to advancements in colonoscopy techniques, potentially improving comfort and efficiency for future patients.

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 prior data suggests that this technique is safe for colonoscopy?

Research has shown that adding a cap to the colonoscope during a water exchange (WE) procedure can help reduce pain. Studies indicate that this cap-assisted method, known as WECAC, makes inserting the colonoscope less painful than the standard WE procedure.

Evidence suggests that patients tolerate the WECAC method well. It not only reduces pain but also speeds up the insertion process, making the procedure quicker and potentially more comfortable. Overall, the WECAC method appears safe, with no additional negative effects reported in these studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial for cap-assisted colonoscopy because it could offer a more comfortable and efficient procedure compared to traditional methods. Standard colonoscopy techniques often use air to expand the colon, which can cause discomfort. In this trial, the water exchange method replaces air with water, and the addition of a cap on the colonoscope may further streamline the insertion process, potentially reducing both pain and time needed for the procedure. By exploring these innovations, the trial aims to improve patient experience during colonoscopies.

What evidence suggests that the WECAC method is effective for reducing pain and insertion time during colonoscopy?

Research has shown that the water exchange (WE) method can reduce pain and the need for medication during a colonoscopy. In this trial, participants will join one of two groups. One group will undergo the WE method, which involves removing air from the colon and replacing it with water to guide the colonoscope. The other group will receive WE plus cap-assisted colonoscopy (WECAC), where a cap is added to the colonoscope. Studies indicate that this cap-assisted approach can further lessen pain and speed up the process of reaching the cecum, the start of the large intestine. WECAC has improved the detection of adenomas, polyps that can develop into cancer. For patients who are not sedated, both the WE and cap-assisted methods independently reduce pain, with WECAC potentially providing the most comfort and efficiency. Overall, evidence supports WECAC as a promising way to make colonoscopies less painful and more effective. ^{2 4 5 6 7}

Who Is on the Research Team?

Felix W Leung, MD

Principal Investigator

VA Greater Los Angeles Healthcare System

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/59/NCT03160859/Prot_000.pdf

Prospective RCT Of Water Exchange (WE) vs. WE Plus ... Cap-assisted colonoscopy aided by air (34) reduced insertion pain, shortened cecal intubation time and increased polyp (34) or adenoma (36,37) detection. A ...

2. journals.lww.com journals.lww.com/ajg/fulltext/2023/10001/s740_real_time_maximum_insertion_pain_in_unsedated.1096.aspx

S740 Real Time Maximum Insertion Pain in Unsedated... Water exchange (WE) and caP-assisted colonoscopy independently reduced insertion pain in unsedated colonoscopy. In pilot investigation, WE combined with cap ...

3. clinicaltrial.be clinicaltrial.be/en/details/68479?per_page=20&only_recruiting=0&only_eligible=0&only_active=0

Water Exchange (WE) vs. WE Plus Cap-assisted ... Water exchange (WE) method has been shown to reduce medication requirement and pain experience during the colonoscopy. Cap-assisted ...

4. centerwatch.com centerwatch.com/clinical-trials/listings/NCT03543124/water-exchange-we-vs-we-plus-cap-assisted-colonoscopy

Water Exchange (WE) vs. WE Plus Cap-assisted ... Water exchange (WE) method has been shown to reduce medication requirement and pain experience during the colonoscopy. Cap-assisted ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7584059/

Impact of cap-assisted colonoscopy during ... We hypothesized that cap-assisted colonoscopy (CC) might reduce the second cecal intubation time and bring potential benefits during the TET procedure.

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39053653/

Prospective randomized controlled trial of water exchange ... We hypothesized that compared with WE, WE cap-assisted colonoscopy (WECAC) could significantly lower real-time maximum insertion pain (RTMIP).

7. grantome.com grantome.com/grant/NIH/I01-CX001418-03

Prospective RCT of Water exchange (WE) vs. WE plus Cap ... Insertion water exchange (WE) is significantly less painful than air insufflation. The addition of cap-assisted colonoscopy (WECAC) further reduces pain ...