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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01530191
Other study ID # shobeiridepression_10.18.11
Secondary ID
Status Withdrawn
Phase N/A
First received January 19, 2012
Last updated October 15, 2013
Start date September 2011
Est. completion date June 2013

Study information

Verified date October 2013
Source University of Oklahoma
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Female
Age group 21 Years and older
Eligibility 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

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma

Sponsors (1)

Lead Sponsor Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Perioperative complications 1 week No
Primary Analgesic use 1 week No
Primary Length of hospital stay 1 week No
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