Trial Outcomes & Findings for Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study (NCT NCT01705288)
NCT ID: NCT01705288
Last Updated: 2020-02-17
Results Overview
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
Recruitment status
COMPLETED
Study phase
EARLY_PHASE1
Target enrollment
103 participants
Primary outcome timeframe
1 Month
Results posted on
2020-02-17
Participant Flow
Participant milestones
| Measure |
Control Group (Standard Laparotomy)
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
|
Rapid Recovery Group
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 Study
STARTED
|
52
|
51
|
|
Overall Study
COMPLETED
|
52
|
51
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Baseline characteristics by cohort
| Measure |
Control Group (Standard Laparotomy)
n=52 Participants
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
|
Rapid Recovery Group
n=51 Participants
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
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
56.0 years
n=5 Participants
|
55.4 years
n=7 Participants
|
55.65 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
52 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
52 participants
n=5 Participants
|
51 participants
n=7 Participants
|
103 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 MonthPopulation: Individuals randomized who underwent eligible surgery
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
Outcome measures
| Measure |
Control Group (Standard Laparotomy)
n=52 Participants
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
|
Rapid Recovery Group
n=51 Participants
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
|
|---|---|---|
|
Hospital Stay
|
3.0 Days
Interval 2.0 to 3.0
|
3.0 Days
Interval 2.0 to 3.0
|
SECONDARY outcome
Timeframe: Post operative - day 2Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.
Outcome measures
| Measure |
Control Group (Standard Laparotomy)
n=51 Participants
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
|
Rapid Recovery Group
n=48 Participants
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
|
|---|---|---|
|
Pain Medications Used
|
10.0 Morphine equivalents
Interval 8.3 to 12.3
|
7.5 Morphine equivalents
Interval 3.3 to 10.0
|
SECONDARY outcome
Timeframe: Day 0Population: Measured in early patients only
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.
Outcome measures
| Measure |
Control Group (Standard Laparotomy)
n=17 Participants
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
|
Rapid Recovery Group
n=19 Participants
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
|
|---|---|---|
|
Pain Assessment
|
4.33 Score on a scale
Interval 3.0 to 6.25
|
3.13 Score on a scale
Interval 2.3 to 4.4
|
Adverse Events
Control Group (Standard Laparotomy)
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Rapid Recovery Group
Serious events: 4 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Control Group (Standard Laparotomy)
n=52 participants at risk
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
|
Rapid Recovery Group
n=51 participants at risk
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
|
|---|---|---|
|
General disorders
ICU admission
|
1.9%
1/52 • 1 year
|
5.9%
3/51 • 1 year
|
|
Blood and lymphatic system disorders
Hemorrhage
|
0.00%
0/52 • 1 year
|
2.0%
1/51 • 1 year
|
Other adverse events
| Measure |
Control Group (Standard Laparotomy)
n=52 participants at risk
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
|
Rapid Recovery Group
n=51 participants at risk
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
|
|---|---|---|
|
General disorders
Individual adverse events breakup not known
|
7.7%
4/52 • 1 year
|
13.7%
7/51 • 1 year
|
Additional Information
Dr. Peter Argenta
Masonic Cancer Center at University of Minnesota
Phone: 612-626-6283
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place