Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Overview
- Phase
- Early Phase 1
- Status
- Completed
- Enrollment
- 103
- Locations
- 1
- Primary Endpoint
- Hospital Stay
Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
- •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
Arms & Interventions
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Intervention: Laparotomy (Procedure)
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Intervention: intravenous narcotics (Drug)
Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Intervention: standard anesthesia (Drug)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
Intervention: Laparotomy (Procedure)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
Intervention: regional anesthesia (Drug)
Rapid Recovery Group
Protocol for "rapid recovery laparotomy" procedure involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), post-operative use of non-steroidal anti-inflammatory drugs, early eating after surgery, early walking, and certain goals for discharge from the hospital.
Intervention: Non-steroidal anti-inflammatory drugs (Drug)
Outcomes
Primary Outcomes
Hospital Stay
Time Frame: 1 Month
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
Secondary Outcomes
- Pain Medications Used(Post operative - day 2)
- Pain Assessment(Day 0)