Colonoscope Type for Obesity

Overseen By Akram Ahmad, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Cleveland Clinic Florida

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 aims to determine whether an adult or pediatric colonoscope is more effective for individuals with a body mass index (BMI) over 30 undergoing routine colonoscopy procedures. Both types of scopes are commonly used, but doctors currently select them based on personal preference and availability. Individuals living with obesity (BMI over 30) and scheduled for a screening or surveillance colonoscopy may be suitable candidates for this study. As an unphased trial, it offers a unique opportunity to contribute to medical knowledge and potentially enhance colonoscopy procedures for others with similar health profiles.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these colonoscopes are safe for people with obesity?

Research has shown that colonoscopies are generally safe, though they can be more challenging for individuals with obesity. A large study found that obese individuals often have a lower success rate in completing colonoscopies, meaning the procedure might not always reach the end of the colon as intended. However, this issue pertains more to the procedure's effectiveness than its safety.

For the smaller pediatric colonoscope, the risk of bleeding is very low, estimated at just 0.43% in children. This suggests it is also quite safe for adults, even those with higher body weight.

Both types of colonoscopes are already used in medical practice, supporting their safety. Some discomfort or longer procedure times may occur, especially for those with a higher body mass index (BMI), but serious problems are rare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of different types of colonoscopes for obesity management because this approach explores how the size and flexibility of the colonoscope might impact patient comfort and procedural effectiveness. Unlike traditional colonoscopy tools, which are typically standardized, this trial compares adult and pediatric colonoscopes to see if one offers better outcomes for individuals with obesity. This could lead to more personalized and comfortable colonoscopy experiences, potentially improving patient compliance and overall health outcomes.

What evidence suggests that this trial's colonoscope types could be effective for obesity?

This trial will compare the effectiveness of adult colonoscopes with pediatric colonoscopes in patients who are overweight or obese. Studies have shown that colonoscopies using adult-sized scopes achieve a 99.9% success rate in reaching the end of the colon. However, for individuals who are overweight or obese, the procedure may not always be completed as easily. In such cases, smaller scopes, like those used for children, can effectively reach the end of the colon. Both types of scopes offer advantages, but some research suggests that the adult-sized scope may provide a more reliable complete exam in obese patients. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for individuals with a BMI over 30 who need a routine colonoscopy, either as a regular check-up or to keep an eye on existing conditions. It's not suitable for those with inflammatory bowel disease, previous colon surgery, or if they've had trouble completing a colonoscopy before due to technical issues.

Inclusion Criteria

My BMI is over 30.

I am undergoing regular colonoscopy checks.

Exclusion Criteria

My procedure was stopped because of blockage or a large stool mass.

I have inflammatory bowel disease.

History of incomplete colonoscopy due to technical difficulties

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 an adult or pediatric colonoscope to determine which is more effective in obese patients

1 day

1 visit (in-person)

Follow-up

Participants are monitored for any immediate post-procedure complications and effectiveness of the colonoscope used

1-2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Colonoscopy

Trial Overview

The study aims to determine whether pediatric or adult colonoscopes are more effective in obese patients undergoing screening and surveillance colonoscopies. Participants will be randomly assigned one of the two types of scopes after their bowels have been cleansed.

How Is the Trial Designed?

Group I: Adult Colonoscope Active Control 1 Intervention

Adult colonoscope

Group II: Pediatric Colonoscope Active Control 1 Intervention

Pediatric colonoscope

Who Is Running the Clinical Trial?

Cleveland Clinic Florida

Lead Sponsor

Trials

16

Recruited

6,800+

Published Research Related to This Trial

In a study of 1986 patients, those with a low body mass index (LBMI) of 18.5 or less experienced a higher rate of serious adverse events (SAE) after endoscopic procedures, with an odds ratio of 1.76, indicating a significant risk factor.

Specifically, infections were more common in the LBMI group (2.1%) compared to the normal weight group (0.8%), highlighting the need for careful monitoring and management of patients with LBMI during endoscopic procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Association Between Low Body-Mass Index and Serious Post-endoscopic Adverse Events. Glaubach, N., Ben Hur, D., Korytny, A., et al.[2023]

Starting colonoscopy in the prone position for obese patients significantly reduces cecal intubation times (average of 424 seconds) compared to the standard left-lateral position (average of 550 seconds), based on a study of 101 patients.

Prone positioning also decreases the need for patient repositioning during the procedure (8% in the prone group vs. 28% in the standard group) and is well tolerated, with no significant difference in pain reported between the two positions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prone positioning of obese patients for colonoscopy results in shortened cecal intubation times: a randomized trial. Uddin, FS., Iqbal, R., Harford, WV., et al.[2021]

In a study of 27,696 colonoscopy procedures, patients with a BMI of 30 or higher had significantly higher odds of experiencing incomplete colonoscopies, longer procedure times, and poorer tolerance compared to those with normal BMI.

The research highlighted that inadequate bowel preparation was most prevalent in patients with class III obesity, indicating a need for improved pre-procedure management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and tolerability of colonoscopies in overweight and obese patients: Results from a national database on gastrointestinal endoscopic outcomes. Passi, M., Rahman, F., Koh, C., et al.[2022]

In a study of 75,278 patients, individuals with higher body mass index (BMI) showed significantly increased rates of adenoma and advanced neoplasia detection during screening colonoscopy, indicating a higher risk for colorectal cancer (CRC) in obese individuals.

Interestingly, despite poorer preparation for colonoscopy in those with higher BMI, the procedure was better tolerated, and the caecal intubation rate improved, suggesting that screening colonoscopy is particularly important for individuals with obesity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of obesity with colonic findings in screening colonoscopy in a large population-based study. Kobiela, J., Wieszczy, P., Reguła, J., et al.[2022]

Obesity is linked to a higher risk of developing colorectal cancer and adenomatous polyps, which are precursors to cancer.

Obese individuals may experience poorer bowel preparation for colonoscopy, potentially leading to reduced detection rates of adenomas during the procedure.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Colonic complications of obesity. Burke, CA.[2017]

A study involving 132 super obese patients (BMI ≥ 50) and 132 non-obese controls found that general endoscopic procedures can be safely performed with moderate sedation, achieving a 100% completion rate for both groups.

Super obese patients required higher doses of sedation medications and experienced a higher rate of brief intra-procedure hypoxia (5% vs 0% in controls), but there were no differences in delayed adverse events between the two groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Moderate Sedation in Super Obese Patients Undergoing Lower and Upper GI Endoscopy: a Case-Control Study. Benson, M., Hubers, J., Caldis, M., et al.[2021]

In a study analyzing 813 colonoscopy cases, factors such as male sex, younger age, higher BMI, and good bowel preparation were associated with shorter cecal intubation times, suggesting these characteristics can help identify cases suitable for endoscopists in training.

Out of 562 cases handled by trainees, 194 were deemed eligible for them to perform independently, indicating that careful selection based on patient characteristics like hypertension and bowel preparation quality can enhance training opportunities while ensuring patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between obesity and metabolic syndrome-related factors and cecal intubation time during colonoscopy. Kawasato, R., Hashimoto, S., Shirasawa, T., et al.[2020]

In a study of 2020 subjects undergoing their first screening colonoscopy, obesity and metabolic syndrome were found to significantly increase the prevalence of colorectal neoplasia, particularly adenomas and advanced adenomas, especially in overweight and obese individuals.

The study revealed that hypertension, hyperlipidemia, and diabetes mellitus also contributed to higher odds of neoplasia, with obesity alone being a strong predictor of neoplasia across all segments of the colon.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obesity Increases Prevalence of Colonic Adenomas at Screening Colonoscopy: A Canadian Community-Based Study. Shapero, TF., Chen, GI., Devlin, T., et al.[2022]

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Colonoscope Type for Obesity

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Efficacy and tolerability of colonoscopies in overweight and ...

Compared to the normal BMI group, a BMI ≥ 30 and < 40 kg/m2 was associated with an increased odds of an incomplete colonoscopy (P = 0.001for ...