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OpenTrials
Completed

NCT Number: NCT01967446

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

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.

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Key information

Age range

60 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse

    Time frame: 1 year

    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

Secondary outcomes

  1. Predictors of Post Operative Morbidity in Older Women with Pelvic Organ Prolapse

    Time frame: 1year

    Secondary outcomes will be change in functional status scores at 6 weeks postoperatively.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Oct 22, 2013
Registry last updated
Dec 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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