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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705288
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterine Endometrial Cancer Ovarian Cancer Procedure: Laparotomy Drug: intravenous narcotics Drug: standard anesthesia Drug: regional anesthesia Drug: Non-steroidal anti-inflammatory drugs Early Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 103 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Actual Study Start Date : January 1, 2013
Actual Primary Completion Date : August 24, 2016
Actual Study Completion Date : August 24, 2016


Arm Intervention/treatment
Active Comparator: Control Group (Standard Laparotomy)
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
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

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.
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: 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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain Medications Used [ Time Frame: Post operative - day 2 ]
    Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.

  2. Pain Assessment [ Time Frame: Day 0 ]
    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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01705288


Locations
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United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
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Principal Investigator: Peter Argenta, M.D. Masonic Cancer Center, University of Minnesota
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01705288    
Other Study ID Numbers: 2012LS096
First Posted: October 12, 2012    Key Record Dates
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by Masonic Cancer Center, University of Minnesota:
laparotomy
hysterectomy
Additional relevant MeSH terms:
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Endometrial Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Neoplasms
Uterine Diseases
Anti-Inflammatory Agents, Non-Steroidal
Morphine
Narcotics
Anesthetics
Anti-Inflammatory Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Antirheumatic Agents