Factors Affecting Perioperative Outcomes

NCT01530191 | Withdrawn

• 1 other identifier: shobeiridepression_10.18.11
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Keywords

depression; anxiety; pelvic organ prolapse; POP

Outcome Measures

Primary Outcomes (3)

• Perioperative complications

  1 week

• Analgesic use

  1 week

• Length of hospital stay

  1 week

Study Arms (2)

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.

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Age at least 21
• Scheduled to undergo surgery for the treatment of pelvic organ prolapse at the University of Oklahoma Health Sciences Center

You may not qualify if:

• Age \< 21
• Inability to complete the written questionnaires
• Undergoing concurrent procedures for condition other than pelvic organ prolapse

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse; Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Mikio Nihira, MD

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 19, 2012
• First Posted: February 9, 2012
• Study Start: September 1, 2011
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: October 16, 2013

Record last verified: 2013-10

Locations

US (1)