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

Early Phase 1

Completed

Conditions: Cervical Cancer
Uterine Endometrial Cancer
Ovarian Cancer

Interventions: Procedure: Laparotomy
Drug: intravenous narcotics
Drug: regional anesthesia
Drug: standard anesthesia
Drug: Non-steroidal anti-inflammatory drugs

Registration Number: NCT01705288

Lead Sponsor: 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.

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).

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 103

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (Standard Laparotomy)	Laparotomy	Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Control Group (Standard Laparotomy)	intravenous narcotics	Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Control Group (Standard Laparotomy)	standard anesthesia	Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Rapid Recovery Group	Laparotomy	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.
Rapid Recovery Group	regional anesthesia	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.
Rapid Recovery Group	Non-steroidal anti-inflammatory drugs	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.

Primary Outcome Measures

Name	Time	Method
Hospital Stay	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

Name	Time	Method
Pain Medications Used	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.
Pain Assessment	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.