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

NCT01705288 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 103

Last updated 2020-02-17

Study results available
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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.

Conditions

Interventions

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

DRUG

standard anesthesia

inhalant or intravenous during surgery

DRUG

regional anesthesia

given by spinal or epidural infusion

DRUG

Non-steroidal anti-inflammatory drugs

given for pain management after surgery

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Peter Argenta, M.D. · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-01-01
Primary Completion
2016-08-24
Completion
2016-08-24

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01705288 on ClinicalTrials.gov