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


Phase 0
19 Years
N/A
Open (Enrolling)
Both
Gynecologic Surgery

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Trial Information

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


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).


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Return to Function

Outcome Description:

The primary outcome of this study is a reduction of length of hospital stay from a mean of 5 days to 3 days.

Outcome Time Frame:

1 Months

Safety Issue:

No

Principal Investigator

Peter Argenta, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2012LS096

NCT ID:

NCT01705288

Start Date:

January 2013

Completion Date:

May 2014

Related Keywords:

  • Gynecologic Surgery
  • laparotomy
  • hysterectomy

Name

Location

Masonic Cancer Center, University of MinnesotaMinneapolis, Minnesota  55455