Trial · NCT03298945
Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
NCT03298945, Phase 4, Completed, VA Office of Research and Development; results first posted 2025-01-22
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens. Trials, record NCT03298945. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03298945
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparative Effectiveness of Split-Dose Colonoscopy Bowel Preparation Regimens
- NCT number
- NCT03298945
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 2,239 participants, actual
- Lead sponsor
- VA Office of Research and Development
- Conditions
- Colorectal Cancer
- Interventions
- Miralax-Gatorade Prep, Golytely
- First posted
- 2017-10-02
- Last updated
- 2025-02-05
- Results first posted
- 2025-01-22
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Colonoscopy Completion Rate | This outcome is determined within 1 month after 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. |
| Primary | Population Level Adenoma Detection Rate (ADR) | within 1 month of colonoscopy | the ADR is estimated as the proportion of patients with at least one adenoma detected among all patients scheduled for colonoscopy. |
| Secondary | Cancellation or No-show in Each Bowel Prep Arm | within 1 month after colonoscopy | The proportion of patients who cancel or no-show in each group. |
| Secondary | Adequate Bowel Prep Quality | within 1 month after the colonoscopy | this is a binary indictor based on endoscopist rating of excellent or good quality bowel preparation |
| Other | Patients With Inadequate Bowel Preparation Who Are Recommended to Have Earlier-than-usual Follow-up Colonoscopy | within 1 month after colonoscopy | patients with inadequate bowel preparation who are recommended to have earlier-than-usual follow-up colonoscopy |
| Other | Hyponatremia | within 6 months after colonoscopy | Hyponatremia |
| Other | Renal Failure | within 6 months of colonoscopy | renal failure documented in CPRS |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Colonoscopy Completion Rate | This outcome is determined within 1 month after colonoscopy | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Population Level Adenoma Detection Rate (ADR) | within 1 month of colonoscopy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Cancellation or No-show in Each Bowel Prep Arm | within 1 month after colonoscopy | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Adequate Bowel Prep Quality | within 1 month after the colonoscopy | |||
| OTHER_PRE_SPECIFIED | Patients With Inadequate Bowel Preparation Who Are Recommended to Have Earlier-than-usual Follow-up Colonoscopy | within 1 month after colonoscopy | |||
| OTHER_PRE_SPECIFIED | Hyponatremia | within 6 months after colonoscopy | |||
| OTHER_PRE_SPECIFIED | Renal Failure | within 6 months of colonoscopy |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Colonoscopy Completion Rate | Golytely | 591 | Participants | ||
| Colonoscopy Completion Rate | Miralax-Gatorade Prep | 600 | Participants | ||
| Population Level Adenoma Detection Rate (ADR) | Golytely | 383 | Participants | ||
| Population Level Adenoma Detection Rate (ADR) | Miralax-Gatorade Prep | 364 | Participants | ||
| Cancellation or No-show in Each Bowel Prep Arm | Golytely | 358 | Participants | ||
| Cancellation or No-show in Each Bowel Prep Arm | Miralax-Gatorade Prep | 330 | Participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Golytely | 1,139 | |
| Overall Study | STARTED | Miralax-Gatorade Prep | 1,100 | |
| Overall Study | COMPLETED | Golytely | 1,139 | |
| Overall Study | COMPLETED | Miralax-Gatorade Prep | 1,100 | |
| Overall Study | NOT COMPLETED | Golytely | 0 | |
| Overall Study | NOT COMPLETED | Miralax-Gatorade Prep | 0 |
Source ClinicalTrials.gov
Adverse events10
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| serious | Colorectal cancer diagnosed on colonoscopy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Golytely | 2 | 1,139 | 2 |
| serious | Colorectal cancer diagnosed on colonoscopy | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Miralax-Gatorade Prep | 5 | 1,100 | 5 |
| serious | Hospitalization for mania and psychosis | Psychiatric disorders | Golytely | 1 | 1,139 | 1 |
| serious | Hospitalization for mania and psychosis | Psychiatric disorders | Miralax-Gatorade Prep | 0 | 1,100 | 0 |
| serious | Hospitalization for lung surgery | Respiratory, thoracic and mediastinal disorders | Golytely | 1 | 1,139 | 1 |
| serious | Hospitalization for lung surgery | Respiratory, thoracic and mediastinal disorders | Miralax-Gatorade Prep | 0 | 1,100 | 0 |
| serious | Hospitalization for respiratory distress | Respiratory, thoracic and mediastinal disorders | Golytely | 1 | 1,139 | 1 |
| serious | Hospitalization for respiratory distress | Respiratory, thoracic and mediastinal disorders | Miralax-Gatorade Prep | 0 | 1,100 | 0 |
| serious | Hospitalization for DKA | Endocrine disorders | Golytely | 1 | 1,139 | 1 |
| serious | Hospitalization for DKA | Endocrine disorders | Miralax-Gatorade Prep | 0 | 1,100 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Golytely | 7 | 1,139 |
| Total, all-cause mortality | Miralax-Gatorade Prep | 4 | 1,100 |
| Total, other adverse events | Golytely | 0 | 1,139 |
| Total, other adverse events | Miralax-Gatorade Prep | 0 | 1,100 |
| Total, serious adverse events | Golytely | 6 | 1,139 |
| Total, serious adverse events | Miralax-Gatorade Prep | 5 | 1,100 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons5
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Golytely vs Miralax-Gatorade Prep: Population Level Adenoma Detection Rate (ADR) | Trial comparisons |
| Golytely vs Miralax-Gatorade Prep: Cancellation or No-show in Each Bowel Prep Arm | Trial comparisons |
| Golytely vs Miralax-Gatorade Prep: Colonoscopy Completion Rate | Trial comparisons |
| Golytely vs Miralax-Gatorade Prep: deaths from any cause | Trial comparisons |
| Golytely vs Miralax-Gatorade Prep: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03298945
GET https://conductscience.org/api/trials/v1/NCT03298945/registered