Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Conditions
Cervical Cancer - Uterine Endometrial Cancer - Ovarian Cancer
Conditions: official terms
Endometrial Neoplasms - Uterine Cervical Neoplasms
Conditions: Keywords
laparotomy, hysterectomy
Study Type
Interventional
Study Phase
Phase 0
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Intervention
Name: Laparotomy Type: Procedure
Name: intravenous narcotics Type: Drug
Name: standard anesthesia Type: Drug
Name: regional anesthesia Type: Drug
Name: Non-steroidal anti-inflammatory drugs Type: Drug
Overall Status
Recruiting
Summary
Over 600,000 hysterectomies are performed annually in the United States. Despite increasing use of less invasive approaches, the majority of hysterectomies are still performed via traditional laparotomy, which can be associated with generally slower recovery and longer lengths of post-operative hospitalization. Rapid Recovery Protocols (RRP) seek to optimize post-surgical morbidity outcomes by returning a patient to normal physiology as quickly as possible following surgery.
Detailed Description
Subjects will be randomly assigned to one of two groups: Rapid recovery protocol (regional anesthesia, pain control options with emphasis on nonsteroidal anti-inflammatory drugs (NSAIDS) over narcotic pain medications, early ambulation, and early enteral feeding) or standard of care (traditional laparatomy and supportive care).
Criteria for eligibility
Healthy Volunteers: Accepts Healthy Volunteers
Maximum Age: N/A
Minimum Age: 19 Years
Gender: Both
Criteria: Inclusion Criteria:

- Women who are being seen at the Women's Health Center by the Gynecologic Oncology group at the University of Minnesota if planned surgery includes an exploratory laparotomy

Exclusion Criteria:

- < 19 years old

- Pregnant

- Undergoing a procedure other than laparotomy

- Scheduled to be discharged the same day of surgery

- Chronic narcotic pain medication user

- American Society of Anesthesiologists (ASA) score of > or = 3

- Any condition that would exclude women from undergoing regional anesthesia
Location
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Status: Recruiting
Contact: Peter Argenta, M.D. - 612-626-3111 - argenta@umn.edu
Start Date
January 2013
Completion Date
August 2016
Sponsors
Masonic Cancer Center, University of Minnesota
Source
Masonic Cancer Center, University of Minnesota
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page