Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

Pelvic Organ Prolapse Clinical Trial

Official title:

Predictors of Post Operative Morbidity in Older Women With Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01967446
• Other study ID #: 814338
• Status: Completed
• Phase: N/A
• First received: August 15, 2013
• Last updated: December 8, 2014
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial Summary

The Investigators hypothesize that functional status scores in elderly women undergoing surgery for pelvic organ prolapse will be lower at 6 weeks post-operatively but will have returned to baseline at 12 weeks post-operatively.

The Investigators hypothesize that greater co-morbidity, frailty and worse functional status before surgery are associated with slower functional recovery, prolonged length of stay in a hospital or nursing care institution and greater post-operative complications following surgery for pelvic organ prolapse.

Description:

An increasing number of elderly women are undergoing surgical treatment for pelvic organ prolapse (POP). Based on US Census data1 and the estimated prevalence of pelvic organ prolapse in women 60 and over, an estimated 1.6 million women over 60 are currently affected with pelvic organ prolapse (POP). This number is expected to increase to 3.4 million by 2050. Prior studies show that geriatric patients have unique physiologic vulnerability, and elderly women undergoing surgery are at risk for worse post-operative outcomes than younger women. However, data from the urogynecology literature are conflicting. Some studies show an increased risk for complications as women age while other studies show no significant increased risk. Other evidence suggests that elderly women still are below their baseline quality-of-life status 6 weeks post-operatively. Return to baseline functional status at 6 weeks post-operatively was not improved when these women were randomized to enhanced pre-operative geriatric assessment versus routine care. These studies were limited by low numbers of very old women and women undergoing obliterative surgery, usually recommended for women with higher co-morbidities and lower functional status.

Post-operative outcomes have been traditionally measured in terms of medically documented complications such as infection, organ injury, cardiac and pulmonary complications. However, studies from other surgical specialties suggest that older subjects undergoing surgery can suffer from significant worsening of functional status resulting in disability, need for long-term care, and dependency at home. Objective markers of functional status, co-morbidity and frailty are potential useful predictors of post-operative complications following surgery in the elderly. However, there is lack of data on the functional status of elderly women undergoing POP surgery, as well as on factors influencing recovery from surgery. The goal of our study is to explore the utility of pre-operative markers of functional status, co-morbidities and frailty to explain post-operative morbidities in elderly women undergoing surgical treatment for pelvic organ prolapse.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 60 Years and older

Eligibility

Inclusion Criteria:

• Women over age 60 undergoing either reconstructive or obliterative surgery (for Stage 2 or greater POP 2) English speaking

Exclusion Criteria:

• Women under the age of 60 will be excluded.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Locations

Country	Name	City	State
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse	The primary outcome will be change in functional status scores at 12 weeks postoperatively as determined by Basic and Instrumental Activities of Daily Living as well as the Functional Health	1 year	No
Secondary	Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse	Secondary outcomes will be change in functional status scores at 6 weeks postoperatively.	1year	No