Trial · NCT02677623
Evaluation of Ureteral Patency in the Post-indigo Carmine Era
NCT02677623, Phase 4, Completed, Columbia University; results first posted 2019-05-30
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Evaluation of Ureteral Patency in the Post-indigo Carmine Era. Trials, record NCT02677623. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02677623
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Evaluation of Ureteral Patency in the Post-indigo Carmine Era
- NCT number
- NCT02677623
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 140 participants, actual
- Lead sponsor
- Columbia University
- Conditions
- Ureteral Patency
- Interventions
- Pyridium, Sodium Fluorescein, Mannitol, Normal Saline
- First posted
- 2016-02-09
- Last updated
- 2019-05-30
- Results first posted
- 2019-05-30
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Visual Analog Scale (VAS) | Intraoperative | This is a 10-cm visual analog scale to determine which method of evaluating ureteral patency is most satisfactory to physicians. The smiley face is at one end and the frowning face is at the other end. Smiling is 1 and frowning is 10. The scale is completed by surgeon, anesthesiologist and the circulator by placing an "x" or a "mark" anywhere on the 10 cm line towards how good and or bad each person felt about the of process of patency assessment that was used. Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from a minimum of 0 to a maximum of 100. A higher score indicates greater pain intensity (worse outcome). |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Visual Analog Scale (VAS) | Intraoperative | Inclusion criteria stipulated women age \>18 years who desired elective, scheduled gynecologic or urogynecologic surgery. Women were excluded if they were pregnant; had a known urologic anatomical anomaly; or had a history of adverse reaction or contraindication to use of phenazopyridine, sodium fluorescein, or mannitol. | score on a scale | MEDIAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Visual Analog Scale (VAS) | A- Pyridium | 48 | Full Range 0 to 83 | score on a scale | |
| Visual Analog Scale (VAS) | B- Sodium Fluorescein | 20 | Full Range 0 to 82 | score on a scale | |
| Visual Analog Scale (VAS) | C- Mannitol | 0 | Full Range 0 to 44 | score on a scale | |
| Visual Analog Scale (VAS) | Control- Normal Saline | 28 | Full Range 3 to 96 | score on a scale |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | A- Pyridium | 33 | |
| Overall Study | STARTED | B- Sodium Fluorescein | 32 | |
| Overall Study | STARTED | C- Mannitol | 32 | |
| Overall Study | STARTED | Control- Normal Saline | 33 | |
| Overall Study | COMPLETED | A- Pyridium | 33 | |
| Overall Study | COMPLETED | B- Sodium Fluorescein | 32 | |
| Overall Study | COMPLETED | C- Mannitol | 32 | |
| Overall Study | COMPLETED | Control- Normal Saline | 33 | |
| Overall Study | NOT COMPLETED | A- Pyridium | 0 | |
| Overall Study | NOT COMPLETED | B- Sodium Fluorescein | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events4
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 |
|---|---|---|---|---|---|---|
| other | Transfusion | Blood and lymphatic system disorders | A- Pyridium | 2 | 33 | 2 |
| other | Transfusion | Blood and lymphatic system disorders | B- Sodium Fluorescein | 1 | 32 | 1 |
| other | Transfusion | Blood and lymphatic system disorders | C- Mannitol | 1 | 32 | 1 |
| other | Transfusion | Blood and lymphatic system disorders | Control- Normal Saline | 1 | 33 | 1 |
Source ClinicalTrials.gov
Adverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | A- Pyridium | 0 | 33 |
| Total, all-cause mortality | B- Sodium Fluorescein | 0 | 32 |
| Total, all-cause mortality | C- Mannitol | 0 | 32 |
| Total, all-cause mortality | Control- Normal Saline | 0 | 33 |
| Total, other adverse events | A- Pyridium | 2 | 33 |
| Total, other adverse events | B- Sodium Fluorescein | 1 | 32 |
| Total, other adverse events | C- Mannitol | 1 | 32 |
| Total, other adverse events | Control- Normal Saline | 1 | 33 |
| Total, serious adverse events | A- Pyridium | 0 | 33 |
| Total, serious adverse events | B- Sodium Fluorescein | 0 | 32 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02677623
GET https://conductscience.org/api/trials/v1/NCT02677623/registered