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

Primary Purpose

Cervical Cancer, Uterine Endometrial Cancer, Ovarian Cancer

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Laparotomy
intravenous narcotics
standard anesthesia
regional anesthesia
Non-steroidal anti-inflammatory drugs
Sponsored by
Masonic Cancer Center, University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cervical Cancer focused on measuring laparotomy, hysterectomy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Masonic Cancer Center, University of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control Group (Standard Laparotomy)

Rapid Recovery Group

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 9, 2012
Last Updated
February 4, 2020
Sponsor
Masonic Cancer Center, University of Minnesota
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1. Study Identification

Unique Protocol Identification Number
NCT01705288
Brief Title
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Official Title
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
January 1, 2013 (Actual)
Primary Completion Date
August 24, 2016 (Actual)
Study Completion Date
August 24, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Masonic Cancer Center, University of Minnesota

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Uterine Endometrial Cancer, Ovarian Cancer
Keywords
laparotomy, hysterectomy

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
103 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group (Standard Laparotomy)
Arm Type
Active Comparator
Arm Description
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Arm Title
Rapid Recovery Group
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Laparotomy
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
intravenous narcotics
Other Intervention Name(s)
morphine
Intervention Description
given for pain management after surgery per physician orders
Intervention Type
Drug
Intervention Name(s)
standard anesthesia
Other Intervention Name(s)
general anesthesia
Intervention Description
inhalant or intravenous during surgery
Intervention Type
Drug
Intervention Name(s)
regional anesthesia
Other Intervention Name(s)
local anesthesia
Intervention Description
given by spinal or epidural infusion
Intervention Type
Drug
Intervention Name(s)
Non-steroidal anti-inflammatory drugs
Other Intervention Name(s)
NSAIDs
Intervention Description
given for pain management after surgery
Primary Outcome Measure Information:
Title
Hospital Stay
Description
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Pain Medications Used
Description
Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.
Time Frame
Post operative - day 2
Title
Pain Assessment
Description
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.
Time Frame
Day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Argenta, M.D.
Organizational Affiliation
Masonic Cancer Center, University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Masonic Cancer Center, University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35289396
Citation
Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.
Results Reference
derived
PubMed Identifier
28079776
Citation
Dickson EL, Stockwell E, Geller MA, Vogel RI, Mullany SA, Ghebre R, Witherhoff BJ, Downs LS Jr, Carson LF, Teoh D, Glasgow M, Gerber M, Rivard C, Erickson BK, Hutchins J, Argenta PA. Enhanced Recovery Program and Length of Stay After Laparotomy on a Gynecologic Oncology Service: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):355-362. doi: 10.1097/AOG.0000000000001838.
Results Reference
derived

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

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