Pelvic Organ ProlapsePhase 3NCT02073734
Effects of Preoperative Dexamethasone Study on QOL After Vaginal Reconstructive Surgery for POP
A Phase 3 study testing Dexamethasone in people with Pelvic Organ Prolapse and PONV, run by TriHealth Inc. at 1 site in United States.
Trial summary
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery. Read more about this study
- Who is it for?
- Ages 18 to 81 years, women only
- Conditions the study is for
- Pelvic Organ Prolapse, PONV
- What is being tested?
- Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2013to Aug 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 81 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy
Who cannot join
- Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
- Regional anesthesia for surgical procedure
- Chronic pain requiring opioid treatment daily
- History of allergy to the study medication
- Severe renal and liver disease
- Pregnancy
Show all 14Show fewer
- Non English speaking
- Psychiatric disorder that will preclude completion of questionnaires
- Minor surgery that does not involve overnight admission
- Surgery that does not involve hysterectomy or vaginal intraperitoneal apical suspension
- Hypersensitivity reaction to steroids
- Evidence of systemic fungal infection
- Evidence of any systemic infection
- Uncontrolled diabetes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
Read the detailed description
This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
- Conditions
- Pelvic Organ Prolapse, PONV
- Being tested
- Dexamethasone, Placebo
- Keywords
- pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration
- Medical subject headings
- Pelvic Organ Prolapse, Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Dexamethasone 8mg/IV
PlaceboDrug
Placebo given IV
| Study group | Role | What they receive |
|---|---|---|
| Dexamethasone | Experimental | Dexamethasone Receives: Drug: Dexamethasone |
| Placebo | Placebo comparator | Sterile normal saline solution Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
Measured: up to 20-24 hours after surgery
Secondary outcomes (1)
To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.
Measured: 20-24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- TriHealth Inc.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel N Pauls, MD, Study director, TriHealth Good Samaritan HospitalRachel N Pauls, MD, Principal investigator, TriHeath Good Samaritan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073734
- Sponsor's protocol ID
- 12136-12-081
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2013
- Last updated
- 21 Apr 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Pauls RN, Crisp CC, Oakley SH, Westermann LB, Mazloomdoost D, Kleeman SD, Ghodsi V, Estanol MV. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol. 2015 Nov;213(5):718.e1-7. doi: 10.1016/j.ajog.2015.05.061. Epub 2015 May 29.
PubMed 26032041
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Preoperative Dexamethasone on Postoperative Quality of Recovery Following Vaginal Reconstructive Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02073734
- Acronym / sponsor ID
- 12136-12-081
- Conditions
- Pelvic Organ Prolapse, PONV
- Keywords
- pelvic organ prolapse surgery, dexamethasone, postoperative nausea and vomiting, peroperative administration
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- TriHealth Inc.University, hospital or other
- Study start
- Feb 2013
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 27 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that preoperative administration of 8 mg IV dexamethasone will benefit patients' perceived quality of recovery after surgery.
Detailed description
This is a randomized controlled trial involving single administration of 8 mg Dexamethasone per IV preoperatively among women undergoing vaginal reconstructive surgery for pelvic organ prolapse.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: DexamethasoneDexamethasone |
| Placebo | Placebo comparator | Drug: PlaceboSterile normal saline solution |
Who may qualify
- Ages
- 18 to 81 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women aged 18-81 years old who are scheduled to undergo a major vaginal reconstructive surgery, including hysterectomy with or without hysterectomy
Key exclusion criteria (14 listed)
- Daily use of steroids or antiemetic agents such as Zofran, Reglan, Compazine and Phenargan within one month of surgery
- Regional anesthesia for surgical procedure
- Chronic pain requiring opioid treatment daily
- History of allergy to the study medication
- Severe renal and liver disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneDexamethasone 8mg/IV | Drug | Dexamethasone |
| PlaceboPlacebo given IV | Drug | Placebo |
Primary outcome
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40).
Time frame: up to 20-24 hours after surgery
The QoR-40 is a validated standardized questionnaire that assesses the dimensions of physical functioning, mental health, cognitive functioning, symptoms, role and social functioning, general health perceptions, sleep and energy
1 secondary outcome
To determine if dexamethasone has positive impact on other clinical recovery variables such as nausea, vomiting and pain.
Time frame: 20-24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2016.
- Derived from this study: PubMed 26032041Pauls RN, Crisp CC, Oakley SH, Westermann LB, Mazloomdoost D, Kleeman SD, Ghodsi V, Estanol MV. Effects of dexamethasone on quality of recovery following vaginal surgery: a randomized trial. Am J Obstet Gynecol. 2015 Nov;213(5):718.e1-7. doi: 10.1016/j.ajog.2015.05.061. Epub 2015 May 29.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel N Pauls, MD study director
TriHealth Good Samaritan Hospital
Rachel N Pauls, MD principal investigator
TriHeath Good Samaritan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Dexamethasone in people with Pelvic Organ Prolapse and PONV, run by TriHealth Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint will be scores on the 40- item quality of recovery scoring system (QoR-40). (time frame: up to 20-24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02073734, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2016.