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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01705288
Recruitment Status : Completed
First Posted : October 12, 2012
Results First Posted : February 17, 2020
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Masonic Cancer Center, University of Minnesota

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Supportive Care
Conditions Cervical Cancer
Uterine Endometrial Cancer
Ovarian Cancer
Interventions Procedure: Laparotomy
Drug: intravenous narcotics
Drug: standard anesthesia
Drug: regional anesthesia
Drug: Non-steroidal anti-inflammatory drugs
Enrollment 103
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group
Hide Arm/Group Description

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

Period Title: Overall Study
Started 52 51
Completed 52 51
Not Completed 0 0
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group Total
Hide Arm/Group Description

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

Total of all reporting groups
Overall Number of Baseline Participants 52 51 103
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
52
 100.0%
51
 100.0%
103
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 51 participants 103 participants
56.0
(52.8 to 59.2)
55.4
(52.3 to 58.5)
55.65
(52.8 to 58.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 51 participants 103 participants
Female
52
 100.0%
51
 100.0%
103
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 52 participants 51 participants 103 participants
52 51 103
1.Primary Outcome
Title Hospital Stay
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Individuals randomized who underwent eligible surgery
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group
Hide Arm/Group Description:

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

Overall Number of Participants Analyzed 52 51
Median (95% Confidence Interval)
Unit of Measure: Days
3.0
(2.0 to 3.0)
3.0
(2.0 to 3.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group (Standard Laparotomy), Rapid Recovery Group
Comments Intention to Treat Analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.36
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
2.Secondary Outcome
Title Pain Medications Used
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group
Hide Arm/Group Description:

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

Overall Number of Participants Analyzed 51 48
Median (95% Confidence Interval)
Unit of Measure: Morphine equivalents
10.0
(8.3 to 12.3)
7.5
(3.3 to 10.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group (Standard Laparotomy), Rapid Recovery Group
Comments Intention to Treat Analysis
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
3.Secondary Outcome
Title Pain Assessment
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Measured in early patients only
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group
Hide Arm/Group Description:

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

Overall Number of Participants Analyzed 17 19
Median (95% Confidence Interval)
Unit of Measure: Score on a scale
4.33
(3.0 to 6.25)
3.13
(2.30 to 4.40)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control Group (Standard Laparotomy), Rapid Recovery Group
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.18
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 1 year
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Group (Standard Laparotomy) Rapid Recovery Group
Hide Arm/Group Description

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

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

intravenous narcotics: given for pain management after surgery per physician orders

standard anesthesia: inhalant or intravenous during surgery

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.

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

regional anesthesia: given by spinal or epidural infusion

Non-steroidal anti-inflammatory drugs: given for pain management after surgery

All-Cause Mortality
Control Group (Standard Laparotomy) Rapid Recovery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Control Group (Standard Laparotomy) Rapid Recovery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   1/52 (1.92%)   4/51 (7.84%) 
Blood and lymphatic system disorders     
Hemorrhage   0/52 (0.00%)  1/51 (1.96%) 
General disorders     
ICU admission  [1]  1/52 (1.92%)  3/51 (5.88%) 
Indicates events were collected by systematic assessment
[1]
The reason behind ICU admission is not recorded/details not available
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control Group (Standard Laparotomy) Rapid Recovery Group
Affected / at Risk (%) Affected / at Risk (%)
Total   4/52 (7.69%)   7/51 (13.73%) 
General disorders     
Individual adverse events breakup not known  [1]  4/52 (7.69%)  7/51 (13.73%) 
Indicates events were collected by systematic assessment
[1]
Only the counts of adverse events were available. The details of each adverse events data not available
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Peter Argenta
Organization: Masonic Cancer Center at University of Minnesota
Phone: 612-626-6283
EMail: argenta@umn.edu
Layout table for additonal information
Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT01705288    
Other Study ID Numbers: 2012LS096
First Submitted: October 9, 2012
First Posted: October 12, 2012
Results First Submitted: February 4, 2020
Results First Posted: February 17, 2020
Last Update Posted: February 17, 2020