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Clinical Trials/NCT01530191
NCT01530191
Withdrawn
Not Applicable

Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse

University of Oklahoma1 site in 1 countrySeptember 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pelvic Organ Prolapse
Sponsor
University of Oklahoma
Locations
1
Primary Endpoint
Perioperative complications
Status
Withdrawn
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2011
End Date
June 2013
Last Updated
12 years ago
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Perioperative complications

Time Frame: 1 week

Analgesic use

Time Frame: 1 week

Length of hospital stay

Time Frame: 1 week

Study Sites (1)

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