Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
19 Years
N/A
Both
Gynecologic Surgery
Trial Information
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
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).
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Return to Function
Outcome Description:
The primary outcome of this study is a reduction of length of hospital stay from a mean of 5 days to 3 days.
Outcome Time Frame:
1 Months
Safety Issue:
No
Principal Investigator
Peter Argenta, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
Masonic Cancer Center, University of Minnesota
Authority:
United States: Institutional Review Board
Study ID:
2012LS096
NCT ID:
NCT01705288
Start Date:
January 2013
Completion Date:
May 2014
Related Keywords:
- Gynecologic Surgery
- laparotomy
- hysterectomy
Name | Location |
|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis, Minnesota 55455 |
