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

Early Phase 1CompletedNCT01705288

Masonic Cancer Center, University of Minnesota103 enrolled

Overview

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.

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

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

103

Conditions

Cervical Cancer Uterine Endometrial Cancer Ovarian Cancer

Interventions

LaparotomyPROCEDURE

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

intravenous narcoticsDRUG

given for pain management after surgery per physician orders

standard anesthesiaDRUG

inhalant or intravenous during surgery

regional anesthesiaDRUG

given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugsDRUG

given for pain management after surgery

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 1 Month

Secondary Outcomes

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.

Time frame: 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.

Time frame: Day 0