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

Study Overview
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Brief Summary
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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
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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).

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

Conditions
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Cervical Cancer, Uterine Endometrial Cancer, Ovarian Cancer

Intervention / Treatment
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* Procedure: Laparotomy
* Drug: intravenous narcotics
* Drug: standard anesthesia
* Drug: regional anesthesia
* Drug: Non-steroidal anti-inflammatory drugs


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group (Standard Laparotomy)<br>Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards. | Procedure: Laparotomy<br>* 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<br>Drug: intravenous narcotics<br>* given for pain management after surgery per physician orders<br>* Other names: morphine;Drug: standard anesthesia<br>* inhalant or intravenous during surgery<br>* Other names: general anesthesia;|
| Experimental: Rapid Recovery Group<br>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<br>* 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<br>Drug: regional anesthesia<br>* given by spinal or epidural infusion<br>* Other names: local anesthesia;Drug: Non-steroidal anti-inflammatory drugs<br>* given for pain management after surgery<br>* Other names: NSAIDs;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Medications Used | Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al. | Post operative - day 2 | 
| Pain Assessment | 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. | Day 0 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparotomy, hysterectomy