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Colon Polyp clinical trials

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NCT ID: NCT04889352 Active, not recruiting - Colo-rectal Cancer Clinical Trials

Optimizing Timing of Follow-up Colonoscopy

Start date: July 15, 2021
Phase: N/A
Study type: Interventional

Overall Objective: To optimize timing of surveillance colonoscopy. Principal research question and specific aims: To assess the impact of access to a hand-held application on the timing of surveillance colonoscopy. To assess whether access to the tool improves adherence to recommended guidelines for follow-up colonoscopy intervals. Colonoscopy is commonly used for surveillance of patients with high risk of developing colorectal cancer, including those with family history of colorectal cancer and those with colorectal polyps. The recommended timing of surveillance colonoscopy varies by the estimated risk for development of colorectal cancer. The estimated risk varies by family history of colorectal cancer (number of affected individuals, age of the persons affected with CRC) and characteristics of the colorectal polyps (size, number, and histology of colorectal polyps (tubular or villous; high grade or low-grade dysplasia; sessile serrated polyp, sessile serrated polyp with dysplasia, hyperplastic polyp or traditional serrated adenomas). Guidelines take all of these factors into account in the recommendations for follow-up colonoscopy and hence are difficult to recall for the busy clinicians. Colonoscopy surveillance is frequently performed at shorter or longer than the recommended time intervals. The investigators have developed a smart phone application in which the characteristics of the patients can be inputted and the tool provides the recommended time interval for surveillance colonoscopy, based on North American guidelines. The investigators are proposing a pilot randomized trial to determine sample size estimates for a larger trial to assess the utility of this application in clinical practice.

NCT ID: NCT04837690 Not yet recruiting - Colon Polyp Clinical Trials

UEMR for Medium-sized Pedunculated Colon Polyps

Start date: May 1, 2021
Phase:
Study type: Observational

Underwater EMR (UEMR) is an emerging technique for endoscopic resection. The purpose of this research is to observ wether the UEMR for medium-sized pedunculated polyps is safe and effective.

NCT ID: NCT04805567 Not yet recruiting - Colon Polyp Clinical Trials

Adenoma Miss Rate in Tandem Endocuff-assisted Colonoscopy

Start date: April 1, 2021
Phase:
Study type: Observational

Colonoscopy is a valuable tool in reducing the incidence and mortality from colorectal cancer (CRC). Older back-to-back studies evaluating novel endoscopes indicated that conventional colonoscopy misses almost 20% of adenomas. In order to improve the diagnostic accuracy of colonoscopy and to improve the adenoma detection rate (ADR) (a significant marker of quality), efforts have been made to improve endoscopic techniques, the bowel preparation, to keep slower withdrawal time, and to use new technologies and devices. Since 2012, a new accessory device (Endocuff; ARC Medical Design, Leeds, UK), which is mounted on the tip of the colonoscope has been introduced to the market. The Endocuff is a device that can be mounted on the tip of an endoscope and may assist to inspect a greater surface of the colonic mucosa by pulling backwards, flattening, and stretching the colonic folds as the endoscope is gradually withdrawn. Use of this device may achieve better visualization of the bowel lumen, especially behind folds, and improve stability of the instrument on withdrawal. The aim of this study is to conduct a back-to-back endoscopy study and to evaluate the contribution of Endocuff-assisted colonoscopy to the detection of missed adenomas in a mixed population of colorectal cancer (CRC) screening/surveillance and symptomatic patients.

NCT ID: NCT04797065 Completed - Colorectal Adenoma Clinical Trials

9 Minutes for Tandem Colonoscopy Withdrawal

Start date: March 1, 2021
Phase: N/A
Study type: Interventional

A mean withdrawal time of at least 6 minutes has been considered to be one of the critical quality criterions of colonoscopy. Recently, our group completed a multicenter randomized controlled trial, which proved that prolonging the withdrawal time to 9 minutes could significantly improve the adenoma detection rate of colonoscopists, especially for young colonoscopists and proximal colon. However, it has some limitations in included participates (mixed indications for colonoscopy) and cannot illustrate the impact of withdrawal time on adenoma miss rate in a parallel randomized design. It is necessary to include tandem colonoscopy and adopt strict criteria of the screening population to confirm the effect of the 9-minute withdrawal time on the adenoma miss rate. Therefore, the investigators plan to conduct a multicenter, randomized controlled trial of tandem colonoscopy to compare adenoma miss rate of 6-minute and 9-minute withdrawal in screening population.

NCT ID: NCT04749303 Recruiting - Clinical trials for Colorectal Neoplasms

Impact of Screen Size on Colorectal Adenoma Detection

Start date: July 1, 2020
Phase: N/A
Study type: Interventional

The purpose of this study is to assess whether the use of large screen during colonoscopy will increase adenoma detection rate.

NCT ID: NCT04727814 Active, not recruiting - Colon Polyp Clinical Trials

Comparison of Polyp Detection and False Alarm Rates in Water Exchange and Air Insufflation Colonoscopy

Start date: August 1, 2020
Phase:
Study type: Observational

Water exchange (WE) improves adenoma detection rate (ADR) but missed polyps occur due to human limitations. Computer-aided detection (CADe) improves polyp detection and can overcome human omissions, but a limiting factor is feces and air bubbles related false alarms (FA). WE provides salvage cleansing and can potentially reduce FA. The investigators compared the additional polyp detection rate (APDR) and false alarm rate (FAR) by CADe between WE and air insufflation.

NCT ID: NCT04710706 Completed - Colon Polyp Clinical Trials

Water-only Versus Water-CO2 (Hybrid) Colonoscopy Insertion Technique

WAVE
Start date: March 6, 2021
Phase: N/A
Study type: Interventional

The colonoscopy procedure involves insertion of a thin, flexible tube with a tiny camera inside (colonoscope) passed inside the bowel. To allow passage of the colonoscope and adequate visualisation of the lining of the bowel wall a range of techniques can be used. During colonoscopy, you can distend the colon with water, CO2 and air. Air is no longer recommended for gas insufflation during colonoscopy as it causes pain and excess bowel distention. So the options are water and/or CO2 but it is not entirely clear which combination is the best and at what point during the colonoscopy. In practice, a hybrid technique where both CO2 and water are used during the colonoscopy in used. Here, water is exclusively used to help navigate the sigmoid colon with air pockets suctioned and turbid water exchanged with clean water. From splenic flexure to caecum a mixture of water and CO2 is used. The aim of this study is to assess procedure comfort and efficiency of two different colonoscopy insertion techniques: water-alone insertion of the colonoscope (gas insufflation not allowed on insertion; water exchange technique) versus water-CO2 hybrid insertion (water used predominately to splenic flexure with water/CO2 used to caecum; modified water immersion technique).

NCT ID: NCT04709770 Not yet recruiting - Colon Cancer Clinical Trials

Low-volume vs High-volume Polyethylene Glycol Based Bowel Preparation for Colonoscopy in People Receiving Hemodialysis

PrepDial
Start date: February 1, 2021
Phase: Phase 4
Study type: Interventional

Current American Society for Gastrointestinal Endoscopy (ASGE) and European Society of Gastrointestinal Endoscopy (ESGE) guidelines recommend a split regimen of high-volume (4-liter polyethylene glycol-based preparation) or low-volume (2-liter polyethylene glycol-based solutions or sodium picosulphate plus magnesium citrate) formulations for routine bowel preparation. Some concerns have been raised about the use of oral bowel-cleansing agents in people receiving hemodialysis due to the possibility of secondary intravascular depletion. There is a risk for thrombosis of dialysis access in case of hypotension. The association of hemodialysis treatment and the use of bowel preparations may induce severe hypovolaemia. Finally, the 4-liter intake with high-volume preparations may cause fluid overload in anuric patients. The aim of our study will be to assess in a randomized trial the non-inferiority of a low-volume versus a high-volume polyethylene glycol-based bowel preparation for adequate bowel cleansing in people receiving hemodialysis (primary end-point). We will also compare the low-volume versus the high-volume preparation for other endoscopic and nephrologic relevant clinical outcomes (secondary end-points).

NCT ID: NCT04664543 Terminated - Colorectal Cancer Clinical Trials

Efficacy of Free Versus Low Residue Diet as Preparation for Screening Colonoscopy

CriLi
Start date: December 1, 2019
Phase: N/A
Study type: Interventional

One tricky aspect of the recommendations for colonoscopy prep is diet. This has a significant impact on the experience of the patient or participant in the screening program and, on the other hand, low adherence has been found in some studies despite a potential Hawthorne effect . It is noteworthy that despite its impact on patient experience, it is an area for which little evidence is available, which is why the guidelines give low-quality recommendations and there is probably considerable variability in clinical practice . In the early days of colonoscopy, a liquid diet for 48 hours was mainly recommended, although some centers indicated a low-residue diet or even the commercially available NASA astronaut diet. Later, the indication for a liquid diet was consolidated until finally numerous studies were published in favor of a low-residue diet, managing to increase tolerance and the quality of the preparation . A limitation of the preparation studies must be borne in mind that the colon cleansing rating scales were not introduced until 1999 when the Aronchick scale was published. Although there is solid evidence in favor of a low-residue diet versus a liquid diet, the investigators do not have evidence on how many days of a low-residue diet should be recommended, and this is reflected in the ESGE (European Society of Gastrointestinal Endoscopy) and ASGE (American Society of Gastrointestinal Endoscopy) guidelines . A randomized clinical trial comparing 3 days versus 1 day of a low residue diet has recently been published . There were no statistically significant differences in the rate of adequate preparations (82.7% vs. 85.6% OR 1.2 95% IC 0.72 to 2.15). However, this study has limited statistical power and a design that allows a non-inferiority analysis has not been followed. In relation to this, our research group is finalizing a non-inferiority clinical trial in whose intermediate analysis, with 421 participants, the non-inferiority of 1 day of diet is fulfilled (rate of poor preparation in 1 day 0.95% vs. 4.74% in 3 days; d + 5%, difference -3.78% IC -6.88% to -1.12%) (38). It is likely, taking into account the available evidence and its evolution, that diet plays a secondary role in preparation. Although no studies designed to directly assess this have been conducted, the research group has indirect data. Walter et al, under the hypothesis that the impact of the fractional preparation and the new preparations on the preparation diminished the importance of the diet, conducted a non-inferiority clinical trial between 2012 and 2013 in which they randomized the patients to follow a diet liquid versus low residue for one day and fractional preparation with Moviprep (39). They established a non-inferiority margin of -13.5%. Their results show a rate of good preparation (Boston> 5) in 68/72 (94.4%) in a liquid diet compared to 60/68 (88.2%) in a low-residue diet (p = 0.04) with a difference of -5.08% demonstrating non-inferiority of the low residue diet.

NCT ID: NCT04628052 Terminated - Colon Polyp Clinical Trials

The Effect of Music on Colonoscopy (MUSICOL)

MUSICOL
Start date: November 20, 2020
Phase: N/A
Study type: Interventional

Colonoscopy is an essential tool for diagnostic evaluation for a wide range of gastrointestinal complaints and is considered the gold standard for colorectal cancer screening. This procedure is often associated with patient anxiety both prior to and during the procedure, as well as discomfort,which is managed with procedural sedation.Anticipation of an uncomfortable experience can deter patients from undergoing the procedure despite it being medically indicated. Music has a number of beneficial effects including improving senses of relaxation and well being. Use of music during colonoscopy is inconsistent and there are no society guidelines or recommendations regarding its use. The investigators hypothesize that music will improve the overall patient experience and enhance endoscopist performance.The investigators propose a randomized controlled trial to study effects of music on both the patient experience and endoscopist performance during colonoscopy. Eligible patients will be randomized to two groups: a "music group" and a "no music"control group.Patients in the music group will be asked for their preference of music to be played during their colonoscopy. For patients in the music group, this music will be played in the procedure room during the procedure, while those in the control group will have no music playing. Patient anxiety and pain will be assessed both before and after the procedure.Overall patient experience after the procedure will be assessed on a likert scale. The performance of the endoscopist will be assessed by measuring adenoma detection rate and adenomas per colonoscopy. Additional outcomes to be assessed include total procedure time and amount of sedation required.