Trial · NCT03338400
Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
NCT03338400, Phase 2, Completed, The Cleveland Clinic; results first posted 2019-05-10
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role? Trials, record NCT03338400. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03338400
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Dexamethasone Administration To Improve Patient Recovery In Ambulatory Vaginal Prolapse Surgery: Is There A Role?
- NCT number
- NCT03338400
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 51 participants, actual
- Lead sponsor
- The Cleveland Clinic
- Conditions
- Quality of Recovery, Same Day Surgery, Nausea and Vomiting, Postoperative, Vaginal Prolapse
- Interventions
- Dexamethasone, Normal saline
- First posted
- 2017-11-09
- Last updated
- 2021-04-14
- Results first posted
- 2019-05-10
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Questionnaire: Quality of Recovery 40 | 24 hours | The primary aim is to evaluate whether standard administration of Dexamethasone at the time of anesthesia induction in patients undergoing vaginal reconstructive surgery would result in improved Quality of Recovery. The QoR-40 has 40 items that consider early postoperative health status of patients. These items cover five dimensions including emotional state (9 items), physical comfort (12 items), patient support (7 items), physical independence (5 items) and pain (7 items). All items are rated on a five-point Likert scale from one (worst) to five (best). All negative items were reversed to ease the interpretation. The total score (global score) was computed by summing all items. The minimum and maximum possible scores were 40 and 200, respectively. |
| Secondary | Nausea, Vomiting | 24 hrs | Clinically important nausea \>50 |
| Secondary | Urinary Tract Infections | until 6 weeks | Number of UTIs diagnosed in each group |
| Secondary | Readmissions | 6 weeks | Any patient that is re-admitted to the hospital and the reason for re-admission will be collected. |
| Secondary | Pain Level | 24 hours | numerical pain scale ranges from 0 to 10, where lower scores represent less pain. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Questionnaire: Quality of Recovery 40 | 24 hours | score on a scale | MEAN | |
| SECONDARY | Nausea, Vomiting | 24 hrs | patients with \>50 on nausea scale | participants | NUMBER |
| SECONDARY | Urinary Tract Infections | until 6 weeks | participants | NUMBER | |
| SECONDARY | Readmissions | 6 weeks | Number or ER visits post-op | participants | NUMBER |
| SECONDARY | Pain Level | 24 hours | Pain score from 0-10 | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group10
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Questionnaire: Quality of Recovery 40 | Dexamethasone | 174 | Standard Deviation 14.49 | score on a scale | |
| Questionnaire: Quality of Recovery 40 | Normal Saline | 167 | Standard Deviation 16.02 | score on a scale | |
| Nausea, Vomiting | Normal Saline | 2 | participants | ||
| Nausea, Vomiting | Dexamethasone | 2 | participants | ||
| Urinary Tract Infections | Normal Saline | 1 | participants | ||
| Urinary Tract Infections | Dexamethasone | 2 | participants | ||
| Readmissions | Normal Saline | 4 | participants | ||
| Readmissions | Dexamethasone | 1 | participants | ||
| Pain Level | Normal Saline | 6.04 | Standard Deviation 2.8 | score on a scale | |
| Pain Level | Dexamethasone | 4.77 | Standard Deviation 2.59 | score on a scale |
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 | Dexamethasone | 25 | |
| Overall Study | STARTED | Normal Saline | 26 | |
| Overall Study | COMPLETED | Dexamethasone | 24 | |
| Overall Study | COMPLETED | Normal Saline | 24 | |
| Overall Study | NOT COMPLETED | Dexamethasone | 1 | |
| Overall Study | NOT COMPLETED | Normal Saline | 2 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dexamethasone | 0 | 24 |
| Total, all-cause mortality | Normal Saline | 0 | 24 |
| Total, other adverse events | Dexamethasone | 0 | 24 |
| Total, other adverse events | Normal Saline | 0 | 24 |
| Total, serious adverse events | Dexamethasone | 0 | 24 |
| Total, serious adverse events | Normal Saline | 0 | 24 |
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 |
|---|---|
| Normal Saline vs Dexamethasone: Nausea, Vomiting | Trial comparisons |
| Normal Saline vs Dexamethasone: Readmissions | Trial comparisons |
| Normal Saline vs Dexamethasone: Urinary Tract Infections | Trial comparisons |
| Dexamethasone vs Normal Saline: deaths from any cause | Trial comparisons |
| Dexamethasone vs Normal Saline: 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/NCT03338400
GET https://conductscience.org/api/trials/v1/NCT03338400/registered