Factors Affecting Perioperative Outcomes

Study Overview
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Brief Summary
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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
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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.

Official Title
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Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse

Conditions
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Pelvic Organ Prolapse

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age at least 21 Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center Exclusion Criteria: Age < 21 Inability to complete the written questionnaires Undergoing concurrent procedures for condition other than pelvic organ prolapse

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Abdominal<br>- 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<br>- 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 the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative complications |  | 1 week | 
| Analgesic use |  | 1 week | 
| Length of hospital stay |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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depression, anxiety, pelvic organ prolapse, POP