Factors Affecting Perioperative Outcomes

• ClinicalTrials.gov Identifier: NCT01530191
• Recruitment Status: Withdrawn
• First Posted: February 9, 2012
• Last Update Posted: October 16, 2013
• Sponsor: University of Oklahoma
• Information provided by (Responsible Party): University of Oklahoma

Tracking Information

• First Submitted Date: January 19, 2012
• First Posted Date: February 9, 2012
• Last Update Posted Date: October 16, 2013
• Study Start Date: September 2011
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 6, 2012)

• Perioperative complications [ Time Frame: 1 week ]
• Analgesic use [ Time Frame: 1 week ]
• Length of hospital stay [ Time Frame: 1 week ]

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Factors Affecting Perioperative Outcomes
• Official Title: Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse

Brief 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.

• 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 Type: Observational
• Study Design: Observational Model: Case-Control; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• 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).
• Condition: Pelvic Organ Prolapse
• Intervention: Not Provided

Study Groups/Cohorts

• 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: October 15, 2013): 0
• Original Estimated Enrollment (submitted: February 6, 2012): 334
• Actual Study Completion Date: June 2013
• Actual Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01530191
• Other Study ID Numbers: shobeiridepression_10.18.11
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Oklahoma
• Study Sponsor: University of Oklahoma
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mikio Nihira, MD; University of Oklahoma

• PRS Account: University of Oklahoma
• Verification Date: October 2013