What side effects are associated with this type of intervention?

The Water Exchange (WE) method and Cap-Assisted Colonoscopy (CAC) are techniques used to reduce pain during colonoscopy. The WE method involves using water infusion instead of air insufflation, which can reduce medication requirements and pain. The addition of a cap to the colonoscope (CAC) can further reduce insertion pain and potentially improve adenoma detection rates. Common side effects of these methods may include mild discomfort, bloating, and cramping during the procedure. However, these techniques are generally well-tolerated and aim to minimize the overall pain experience compared to traditional air insufflation methods.

What prior FDA approvals exist?

The Water Exchange plus Cap-Assisted Colonoscopy (WECAC) method aims to reduce pain and improve adenoma detection by adding a cap to the colonoscope during water infusion. While the provided context does not mention specific FDA approvals or related drugs for this exact method, it highlights the general approach of using water infusion to reduce pain during colonoscopy. This method is part of broader efforts to enhance patient comfort and procedural outcomes in colonoscopy, but specific FDA-approved treatments or drugs for real-time maximum insertion pain in this context are not detailed.

What other types of research exist?

Promising alternatives to WECAC for reducing pain and improving adenoma detection in colonoscopy include: 1) Cap-assisted colonoscopy with air insufflation, which has been shown to reduce insertion pain. 2) The use of CO2 insufflation instead of air, which can reduce discomfort and bloating. 3) The application of advanced imaging techniques such as narrow-band imaging (NBI) or chromoendoscopy to enhance adenoma detection. 4) Robotic-assisted colonoscopy, which may offer more precise control and potentially reduce patient discomfort. These methods should be discussed with a healthcare provider to determine the best approach for individual patients.

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Procedure

Cap-Assisted Colonoscopy for Reduced Pain and Insertion Time (VA Trial)

N/A

Waitlist Available

Led By Felix W Leung, MD

Research Sponsored by VA Greater Los Angeles Healthcare System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 hours

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While not explicitly listed in your information provided, typical side effects from these procedures may include discomfort or mild pain due to gas insufflation, bloating, cramping sensations during insertion of the scope or when using water exchange techniques.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Real-time maximum insertion pain(RTMIP) score

Secondary study objectives

Insertion time

Proportion with no insertion pain

Proximal colon ADR

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: WE plus cap(WECAC)Experimental Treatment2 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 Control1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

cap

2017

N/A

~710

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Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The Water Exchange (WE) method reduces Real-time Maximum Insertion Pain (RMIP) by infusing water instead of air during colonoscope insertion, minimizing bowel distension and discomfort. Cap-Assisted Colonoscopy (CAC) adds a cap to the colonoscope, aiding in smoother navigation and reducing mucosal trauma. These techniques are important for RMIP patients as they enhance comfort during the procedure and improve adenoma detection rates, which is vital for effective colorectal cancer screening.