Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
1 other identifier
interventional
103
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for early_phase_1
Started Jan 2013
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 9, 2012
CompletedFirst Posted
Study publicly available on registry
October 12, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 24, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 24, 2016
CompletedResults Posted
Study results publicly available
February 17, 2020
CompletedFebruary 17, 2020
February 1, 2020
3.6 years
October 9, 2012
February 4, 2020
February 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital Stay
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
1 Month
Secondary Outcomes (2)
Pain Medications Used
Post operative - day 2
Pain Assessment
Day 0
Study Arms (2)
Control Group (Standard Laparotomy)
ACTIVE COMPARATORPatients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Rapid Recovery Group
EXPERIMENTALProtocol 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.
Interventions
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
given for pain management after surgery per physician orders
inhalant or intravenous during surgery
given by spinal or epidural infusion
given for pain management after surgery
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \< 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455, United States
Related Publications (2)
Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
PMID: 35289396DERIVEDDickson EL, Stockwell E, Geller MA, Vogel RI, Mullany SA, Ghebre R, Witherhoff BJ, Downs LS Jr, Carson LF, Teoh D, Glasgow M, Gerber M, Rivard C, Erickson BK, Hutchins J, Argenta PA. Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):355-362. doi: 10.1097/AOG.0000000000001838.
PMID: 28079776DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Peter Argenta
- Organization
- Masonic Cancer Center at University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
Peter Argenta, M.D.
Masonic Cancer Center, University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 9, 2012
First Posted
October 12, 2012
Study Start
January 1, 2013
Primary Completion
August 24, 2016
Study Completion
August 24, 2016
Last Updated
February 17, 2020
Results First Posted
February 17, 2020
Record last verified: 2020-02