NCT01705288

Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Accepted

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).

Conditions

• Cervical Cancer
• Uterine Endometrial Cancer
• Ovarian Cancer

Interventions

Type	Name	Description
PROCEDURE	Laparotomy	Exploratory surgery for gynecologic diagnosis.Involves pre-operative counseling, the use of regional anesthesia (spinal or epidural pain management rather than intravenous narcotics), early eating after surgery, early walking, and certain goals for discharge from the hospital
DRUG	intravenous narcotics	given for pain management after surgery per physician orders
DRUG	standard anesthesia	inhalant or intravenous during surgery
DRUG	regional anesthesia	given by spinal or epidural infusion
DRUG	Non-steroidal anti-inflammatory drugs	given for pain management after surgery

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-08-24
• Completion: 2016-08-24
• First posted: 2012-10-12
• Last updated: 2020-02-17
• Results posted: 2020-02-17

Locations

1 site across 1 country: United States