Neoplasms

Digestive System Diseases

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Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Polyethylene glycol 3350

Laxatives

Cathartics

2-L split-dose Miralax-Gatorade bowel prep

2-L split-dose Miralax-Gatorade bowel prep for colonoscopy

Miralax-Gatorade Prep

4-L split dose Golytely is the current standard prep at the VA

Golytely

Yu-Xiao Yang, MD MSCE

From the patients' perspective, the most formidable part of the colonoscopy experience is the process of bowel cleansing. A poorly tolerated bowel preparation regimen often leads to incompletion of scheduled colonoscopies which in turn undermines the effectiveness of colonoscopy, increases cost, and decreases patient satisfaction. The current standard bowel preparation in the VA is of larger volume and less palatable than another commonly used bowel preparation regimen. The investigators propose to compare these two commonly used bowel preparations with respect to the overall completion rate of scheduled colonoscopies in a real-world VA practice setting. The results of the study can be immediately applied to maximize the effectiveness of colonoscopy and increase patient satisfaction in the VA.

Anticipated Impacts on Veterans Health Care: by identifying a colonoscopy bowel preparation regimen which is the most effective in real-world VA practice and can be immediately implemented on a VA-wide scale, the proposed study will maximize the effectiveness of colonoscopy in reducing colorectal cancer (CRC) risk among Veterans, increase Veteran satisfaction, and reduce VA healthcare cost. Background: CRC is a leading cause of cancer-related death among Veterans. Colonoscopy can effectively reduce CRC incidence and mortality. However, non-adherence to screening colonoscopy substantially undermines this benefit. Existing evidence indicates that a disagreeable bowel preparation is a leading barrier to completing a colonoscopy from the patients' perspective. The taste and the volume of the bowel preparation determine patient tolerability and compliance to the preparation instructions, which in turn affects the incompletion (e.g., cancellation/no-show/reschedule) rate of scheduled colonoscopies as well as the effectiveness of the completed colonoscopies and patient satisfaction. The two most commonly used preparations currently in the US are the split-dose 4L polyethylene glycol (PEG) and the split-dose 2L MiraLAX/Gatorade preparations. While a high-volume regimen may in theory be more effective than a lower volume one, it may be associated with lower tolerability and adherence in real-world practice. Three small trials have compared these two preparations. However, data from these explanatory trials cannot inform policy decisions because they were conducted under artificial conditions, restricted among narrow patient populations, and most importantly not designed to capture the full impact of bowel preparation on the completion rate or effectiveness of colonoscopy. To address this critical knowledge gap, the investigators are proposing a pragmatic trial to determine the optimal split-dose bowel preparation in the general Veteran population. Objectives: to compare the real-world effectiveness of the two most commonly used split-dose colonoscopy bowel preparation regimens in the US (i.e., 4L PEG and 2L MiraLAX/Gatorade) with respect to the completion rate of scheduled colonoscopies, adenoma detection rate and secondarily preparation quality, cancellation/no-show rate and patient-oriented outcomes (e.g., willingness to repeat the preparation).

Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens

patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy

The completion rate of scheduled colonoscopy will be defined as the proportion of patients who show up for their scheduled colonoscopy and have endoscopist-rated "adequate" bowel preparation quality, among those scheduled for a colonoscopy.

the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy.

The proportion of patients who cancel or no-show in each group.

this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation

VA Office of Research and Development

Symptoms and General Pathology

Polyps

Pharmaceutical Solutions

Anti-Infective Agents

Antiemetics

Cardiotonic Agents

Herbal and Botanical

Erythromycin

Erythromycin Estolate

Erythromycin Ethylsuccinate

Erythromycin stearate

Metoclopramide

Bisacodyl

Sennosides

Dopamine

Dopamine Antagonists

Dopamine Agents

Neurotransmitter Agents

Anti-Bacterial Agents

Enzyme Inhibitors

Cola

Senna

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

SUPREP oral sulfate solution

SUPREP oral sulfate solution with Gastrografin

Douglas K Rex, Dr.

This study is designed to determine the optimal bowel preparation regimen for PillCam® COLON 2 Capsule Endoscopy System (CCE) procedures in average risk patients.

Patients will be randomized to receive one of two bowel preparation regimens prior to PillCam CCE.

This is a multicenter, prospective, consecutive, randomized study. Average-risk subjects undergoing CCE without optical colonoscopy will be consecutively enrolled and randomized 1:1 to receive one of two bowel preparation regimens prior to PillCam CCE.

Subjects will be enrolled at 5-10 clinical sites in the United States. Subjects who meet the eligibility criteria will be screened for study participation at a baseline visit and will be evaluated on the procedure day or until capsule excretion. A telephone follow-up will be conducted 5 to 9 days post-capsule ingestion to verify capsule excretion, assess patient well-being, and capture any adverse events.

Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure

COVGIC20482: A Multicenter, Consecutive, Randomized Study to Optimize the Bowel Preparation Regimen for the PillCam COLON 2 Capsule Endoscopy Procedure

The primary endpoint is the bowel cleansing level, as determined by a standardized 4-point grading scale, assessed in total and by segment (cecum, ascending, transverse, descending/sigmoid, and rectum).

Will be assessed from RAPID video in total and by segment

Colonic transit time of two different bowel preparation was assessed from RAPID video in total and by segment

Will be assesses by applicable case report form (CRF)

Medtronic - MITG

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Bowel Preparation Regimen -Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

Bowel Preparation Regimen-Test

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

United States

Region of Enrollment

Liron Bar Yaakov

Overall Excellent cleansing

Cecum Excellent cleansing

Ascending Excellent cleansing

Transverse Excellent cleansing

Descending Excellent cleansing

Rectum Excellent cleansing

Overall Good cleansing

Cecum Good cleansing

Ascending Good cleansing

Transverse Good cleansing

Descending Good cleansing

Rectum Good cleansing

Overall Fair cleansing

Cecum Fair cleansing

Ascending Fair cleansing

Transverse Fair cleansing

Descending Fair cleansing

Rectum Fair cleansing

Overall Poor cleansing

Cecum Poor cleansing

Ascending Poor cleansing

Transverse Poor cleansing

Descending Poor cleansing

Rectum Poor cleansing

this was calculated on the per protocol analysis (PPAS) set excluding patients with one (or more) unseen segment in Cecum, Ascending and Transverse colon.

Bowel Cleansing Level of Two Different Bowel Preparation Methods for PillCam® Colon Capsule Endoscopy (CCE)

Overall (any size)

Cecum (any size)

Ascending (any size)

Transverse (any size)

Descending (any size)

rectum (any size)

Overall (polyps ≥6mm)

Cecum (polyps ≥6mm)

Ascending (polyps ≥6mm)

Transverse (polyps ≥6mm)

Descending (polyps ≥6mm)

Rectum (polyps ≥6mm)

Overall (polyps ≥10mm)

Cecum Overall (polyps ≥10mm)

Ascending Overall (polyps ≥10mm)

Transverse (polyps ≥10mm)

Descending (polyps ≥10mm)

Rectum (polyps ≥10mm)

This analysis is a subset of the PPAs excluding patients with one or more missing video data for Cecum, Ascending and transverse colon. Patients with at least one polyp detected on overall segments.

Comparing Polyp Detection Rate of Two Different Bowel Preparation Methods for PillCam CCE

Bowel Preparation Regimen - Control

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution with Gastrografin Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Test

Senna tablets

PEG

Metoclopramide

Erythromycin

Bisacodyl

SUPREP oral sulfate solution with Gastrografin

The following patients were excluded from the analysis:2 withdrawn patients, 1 LTF (Lost to follow-up) patient, 2 pattients with failed prcedure, 16 patients with incomplete COLON exam.

Colonic Transit Time of Two Different Bowel Preparation Methods for PillCam CCE

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of PEG on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure- Control

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Comparing of Completion Rate of Capsule of Two Different Bowel Preparation Methods for PillCam CCE

PPAS: Subjects withdrawn prior to the PillCam procedure (3) and subjects with one or more of the following protocol deviations (13) have been excluded: Evening PEG intake \<1h and \> 2.15h, Morning PEG intake \<1h and \>2:15 h, Capsule ingestion l\<45 min or \>75 min after PEG intake , Overall PEG intake volume is less than 3 liters

Excretion Rate of Capsule Within 12 Hours of Two Different Bowel Preparation Methods for PillCam CCE

Adverse Events Rate Between Two Different Bowel Preparation Methods for PillCam CCE

Regimen includes administration of:

Drug: 4 Senna tablets 2 days before the procedure, Drug: 2-liters of polyethylene glycol (PEG) on the evening before the procedure Drug: 2-liters of PEG on the morning of the procedure, Drug:10mg Metoclopramide or 250 mg Erythromycin Drug: 2 SUPREP oral sulfate solution Drug: 10mg Bisacodyl suppository.

PillCam® COLON 2 procedure-CONTROL

Senna tablets

PEG

Metoclopramide

Erythromycin

SUPREP oral sulfate solution

Bisacodyl

Overall Study

Picosulfate sodium

The intervention is a bowel cleansing procedure

bowel preparation: senna & gastrofin versus picolax (standard)

David Burling

The study will compare patient's experience between those taking a standard bowel cleansing regimen with minimal laxative tagging regimen of senna and gastrofin. Additionally comparing any possible reduction in diagnostic accuracy that may ensue from an increased quantity of retained faecal residue.

Bowel cleansing with high dose laxative is the standard bowel preparation prior to whole colon investigations but such regimens are associated with considerable patient discomfort and inconvenience, potentially affecting compliance rates \[1-3\].

Unlike existing whole colon investigations (conventional colonoscopy and barium enema), reduced laxative regimens can be successfully used with VC, with the aim of improving patient experience, whilst maintaining diagnostic accuracy. These regimens utilize faecal tagging; a method of labeling residual faeces and fluid with radiodense liquids, such as iodine or barium based fluids, which are taken orally by the patient. Once faecal residue and fluid is labeled in this way, it can easily be discriminated from true pathology (which remains 'untagged').

We are proposing to compare different bowel preparation regimens, and ascertain patient experience of the different regimes, while monitoring diagnostic accuracy of the 2 different regiments.

Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience

Virtual Colonoscopy: Comparison of Reduced Laxative Virtual Colonoscopy Regimens With Standard Preparation on Patient Experience and Compliance - a Questionnaire Based Study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens	NCT03298945	Colorectal Canc...	Miralax-Gatorad... Golytely	18 Years -	VA Office of Research and Development
Optimization of the Bowel Preparation Regimen for the PillCam® COLON 2 Capsule Endoscopy Procedure	NCT02481219	Colorectal Canc...	PillCam® COLON ... Senna tablets PEG Metoclopramide Erythromycin SUPREP oral sul... Bisacodyl SUPREP oral sul...	50 Years - 75 Years	Medtronic - MITG
Comparison of Bowel Preparation in Virtual Colonoscopy (VC) - Patient Experience	NCT00460837	Colorectal Canc...	bowel preparati...	18 Years -	London North West Healthcare NHS Trust

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