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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01705288
• Other study ID #: 2012LS096
• Status: Completed
• Phase: Early Phase 1
• Start date: January 1, 2013
• Est. completion date: August 24, 2016

Study information

• Verified date: February 2020
• Source: Masonic Cancer Center, University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 103
• Est. completion date: August 24, 2016
• Est. primary completion date: August 24, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Uterine Endometrial Cancer

Intervention

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
• standard anesthesia
inhalant or intravenous during surgery
• regional anesthesia
given by spinal or epidural infusion
• Non-steroidal anti-inflammatory drugs
given for pain management after surgery

Locations

Country	Name	City	State
United States	Masonic Cancer Center, University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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