Brief Title
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Official Title
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Brief 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).
Study Phase
Early Phase 1
Study Type
Interventional
Primary Outcome
Hospital Stay
Secondary Outcome
Pain Medications Used
Condition
Cervical Cancer
Intervention
Laparotomy
Study Arms / Comparison Groups
Control Group (Standard Laparotomy)
Description: Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
103
Start Date
January 1, 2013
Completion Date
August 24, 2016
Primary Completion Date
August 24, 2016
Eligibility 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
Gender
All
Ages
19 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Peter Argenta, M.D., ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT01705288
Organization ID
2012LS096
Responsible Party
Sponsor
Study Sponsor
Masonic Cancer Center, University of Minnesota
Study Sponsor
Peter Argenta, M.D., Principal Investigator, Masonic Cancer Center, University of Minnesota
Verification Date
February 2020