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

University of Minnesota (UMN)

Status and phase: Completed; Early Phase 1

Conditions: Uterine Endometrial Cancer; Ovarian Cancer; Cervical Cancer

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

Study type: Interventional

Funder types: Other

Identifiers

NCT01705288

2012LS096

Details and patient eligibility

About

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.

Full 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).

Enrollment: 103 patients

Sex: All

Ages: 19+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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103 participants in 2 patient groups

Control Group (Standard Laparotomy)

Active Comparator group

Description:

Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.

Treatment:

Drug: intravenous narcotics

Drug: standard anesthesia

Procedure: Laparotomy

Rapid Recovery Group

Experimental group

Description:

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.

Treatment:

Drug: Non-steroidal anti-inflammatory drugs

Procedure: Laparotomy

Drug: regional anesthesia