Clinical trial NCT01530191: Factors Affecting Perioperative Outcomes
Official title: Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Pelvic Organ Prolapse
Keywords: depression
anxiety
pelvic organ prolapse
POP
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
First posted: 2012-02-09
Enrollment: 0
Sex: FEMALE
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Perioperative complications
timeFrame: 1 week
measure: Analgesic use
timeFrame: 1 week
measure: Length of hospital stay
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Mikio Nihira, MD
role: PRINCIPAL_INVESTIGATOR
References: