Pelvic Organ ProlapseNCT01530191
Factors Affecting Perioperative Outcomes
An observational study of Pelvic Organ Prolapse, run by University of Oklahoma at 1 site in United States.
Trial summary
The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse. Read more about this study
- Who is it for?
- Ages 21 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Jun 2013
- Phase
- Observational
- 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 21 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).
Who may be able to join
- Age at least 21
- Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center
Who cannot join
- Age < 21
- Inability to complete the written questionnaires
- Undergoing concurrent procedures for condition other than pelvic organ prolapse
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
About this study
Official title: Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse
The specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.
- Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
- Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.
A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.
Read the detailed description
Objectives: The purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population.
Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.
- Conditions
- Pelvic Organ Prolapse
- Keywords
- depression, anxiety, pelvic organ prolapse, POP
- Medical subject headings
- Pelvic Organ Prolapse, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal | - Participants undergoing surgeries with an abdominal approach will be given a Morphine PCA at a dose of 2mg every 10 minutes with a 12mg/hour lockout. They will also be given IV Toradol at 30mg every 6 hours as needed for a maximum of four doses. | |
| Vaginal | - Participants undergoing surgeries with a vaginal approach will be given hydrocodone/acetaminophen at a dose of 5/325 (1-2 tablets every four hours as needed), and provided with Ibuprofen 800mg every 8 hours as needed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative complications
Measured: 1 week
Analgesic use
Measured: 1 week
Length of hospital stay
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2012 (estimated)
- Study startSep 2011
- Primary completionJun 2013
- Study completionJun 2013
Why it stopped: No subject accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mikio Nihira, MD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01530191
- Sponsor's protocol ID
- shobeiridepression_10.18.11
- Status last verified
- Oct 2013
- First submitted
- 19 Jan 2012
- Last updated
- 16 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT01530191
- Acronym / sponsor ID
- shobeiridepression_10.18.11
- Conditions
- Pelvic Organ Prolapse
- Keywords
- depression, anxiety, pelvic organ prolapse, POP
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No subject accrual
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 9 Feb 2012 (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 specific aim of this study is to determine if pre-existing depression and anxiety affect perioperative outcomes measures patients undergoing surgery for pelvic organ prolapse.
- Hypothesis 1: Patients with depression will have increased analgesic use and longer hospital stays postoperatively
- Hypothesis 2: Patients with anxiety will have increased analgesic use and longer hospital stays postoperatively.
A secondary aim is to characterize the incidence and severity of depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse.
Detailed description
Objectives: The purpose of this study is to assess preoperative depression and anxiety in patients scheduled to undergo surgery for pelvic organ prolapse and to determine if pre-existing depression and anxiety will affect perioperative outcomes in this patient population.
Methodology: Patients from the University of Oklahoma Urogynecology clinics who have been scheduled to undergo surgery for pelvic organ prolapse will be invited to participate in this study. Informed consent will be obtained prior to study enrollment. Data obtained from a preoperative visit with each participant will include demographic information, medical and surgical histories, and a complete physical examination. After enrollment into the study, each participant will be started on a standardized dose of analgesics. The visual analog scale will be used to assess the level of pain at the surgical site and pain medications will be adjusted as necessary. Information regarding their postoperative course will be tracked, including any complications, use of pain medications, and length of hospital stay.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal | – | –- Participants undergoing surgeries with an abdominal approach will be given a Morphine PCA at a dose of 2mg every 10 minutes with a 12mg/hour lockout. They will also be given IV Toradol at 30mg every 6 hours as needed for a maximum of four doses. |
| Vaginal | – | –- Participants undergoing surgeries with a vaginal approach will be given hydrocodone/acetaminophen at a dose of 5/325 (1-2 tablets every four hours as needed), and provided with Ibuprofen 800mg every 8 hours as needed. |
Who may qualify
- Ages
- 21 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be drawn from the University of Oklahoma Urogynecology clinics. Our catchment area includes OU Physicians clinic (private clinic) and Presbyterian Professional Building (resident clinic).
Key inclusion criteria (2 listed)
- Age at least 21
- Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center
Key exclusion criteria (3 listed)
- Age < 21
- Inability to complete the written questionnaires
- Undergoing concurrent procedures for condition other than pelvic organ prolapse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative complications
Time frame: 1 week
Analgesic use
Time frame: 1 week
Length of hospital stay
Time frame: 1 week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2013.
Related trials for Pelvic Organ Prolapse
Recruiting
Pelvic Floor Muscle Training During Pregnancy
Urinary Incontinence, Anal Incontinence
Not yet recruiting
Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
Pelvic Floor Dysfunction, Perineal Laceration
Not yet recruitingPhase 4
Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
Pelvic Organ Prolapse (POP), Postoperative Pain
Active, not recruiting
Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
Uterine Prolapse
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
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.
Mikio Nihira, MD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Organ Prolapse, run by University of Oklahoma 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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 16 Oct 2013. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Perioperative complications (time frame: 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Oct 2013.