Factors Affecting Perioperative Outcomes

Pelvic Organ Prolapse Clinical Trial

Official title:

Factors Affectign Perioperative Outcomes After Surgery for Pelvic Organ Prolapse

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01530191
• Other study ID #: shobeiridepression_10.18.11
• Status: Withdrawn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• Status: Withdrawn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

• Pelvic Organ Prolapse
• Prolapse

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