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

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ClinicalTrials.gov Identifier: NCT01705288
Recruitment Status : Completed
First Posted : October 12, 2012
Last Update Posted : February 10, 2017
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Tracking Information
First Submitted Date  ICMJE October 9, 2012
First Posted Date  ICMJE October 12, 2012
Last Update Posted Date February 10, 2017
Actual Study Start Date  ICMJE January 1, 2013
Actual Primary Completion Date August 24, 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
Return to Function [ Time Frame: 1 Months ]
The primary outcome of this study is a reduction of length of hospital stay from a mean of 5 days to 3 days.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01705288 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2012)
  • Comparison of Pain Assessment [ Time Frame: Week 1 ]
    Secondary outcome is to determine if rapid recovery can improve Visual Analogue Scale (VAS) for pain assessment. VAS scales are a horizontal line 100 mm in length with the left end labeled 'No pain' and the right end labeled 'Very severe pain'. The subject marks a point on the line that represents their perception of their current state. VAS score is determined by measuring the distance (mm) from the left end of the line to the point on the line marked by the subject. The range of possible values for this pain score is 0 to 100 mm.
  • Comparison of Pain Medications Used [ Time Frame: Week 1 ]
    Another secondary outcome will be whether the rapid recovery protocol decreases the amount of narcotic pain medication used by patients during their hospital stay.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 9, 2012)
  • Comparison of Anti-Emetics Use [ Time Frame: Week 1 ]
  • Comparison of Rates of Readmission to Hospital [ Time Frame: Month 1 ]
  • Comparison of Complications During Readmission [ Time Frame: Month 1 ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Official Title  ICMJE 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 Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Cervical Cancer
  • Uterine Endometrial Cancer
  • Ovarian Cancer
Intervention  ICMJE
  • 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
    Other Name: morphine
  • Drug: standard anesthesia
    inhalant or intravenous during surgery
    Other Name: general anesthesia
  • Drug: regional anesthesia
    given by spinal or epidural infusion
    Other Name: local anesthesia
  • Drug: Non-steroidal anti-inflammatory drugs
    given for pain management after surgery
    Other Name: NSAIDs
Study Arms  ICMJE
  • Active Comparator: Control Group (Standard Laparotomy)
    Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
    Interventions:
    • Procedure: Laparotomy
    • Drug: intravenous narcotics
    • Drug: standard anesthesia
  • Experimental: 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.
    Interventions:
    • Procedure: Laparotomy
    • Drug: regional anesthesia
    • Drug: Non-steroidal anti-inflammatory drugs
Publications * Dickson 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 8, 2016)
112
Original Estimated Enrollment  ICMJE
 (submitted: October 9, 2012)
100
Actual Study Completion Date  ICMJE August 24, 2016
Actual Primary Completion Date August 24, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01705288
Other Study ID Numbers  ICMJE 2012LS096
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Masonic Cancer Center, University of Minnesota
Study Sponsor  ICMJE Masonic Cancer Center, University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Argenta, M.D. Masonic Cancer Center, University of Minnesota
PRS Account Masonic Cancer Center, University of Minnesota
Verification Date February 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP