CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 103 enrolled
Drug / intervention
intravenous narcotics +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01705288
NCT01705288Early Ph 1Completed

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

Masonic Cancer Center, University of Minnesota·interventional·Posted Oct 12, 2012·Updated Feb 17, 2020

In Brief

A Early Phase 1 clinical trial evaluating Laparotomy, intravenous narcotics, and 3 other interventions for Cervical Cancer and 2 related conditions. Completed, enrolled 103 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedOct 12, 2012
Enrollment StartJan 1, 2013
Primary CompletionAug 24, 2016
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 13.7 years ago

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