Cervical Cancer, Uterine Endometrial Cancer, Ovarian Cancer
Conditions
Keywords
laparotomy, hysterectomy
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).
Interventions
PROCEDURELaparotomy
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
given for pain management after surgery per physician orders
inhalant or intravenous during surgery
DRUGregional anesthesia
given by spinal or epidural infusion
given for pain management after surgery
Sponsors
Masonic Cancer Center, University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospital Stay | 1 Month | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Medications Used | Post operative - day 2 | 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 | Day 0 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 52 |
| 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 | 51 |
| Total | 103 |
Baseline characteristics
| Characteristic | Rapid Recovery Group | Control Group (Standard Laparotomy) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants | 52 Participants | 103 Participants |
| Age, Continuous | 55.4 years | 56.0 years | 55.65 years |
| Region of Enrollment United States | 51 participants | 52 participants | 103 participants |
| Sex: Female, Male Female | 51 Participants | 52 Participants | 103 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 52 | 7 / 51 |
| serious Total, serious adverse events | 1 / 52 | 4 / 51 |
Outcome results
Primary
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
Time frame: 1 Month
Population: Individuals randomized who underwent eligible surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group (Standard Laparotomy) | Hospital Stay | 3.0 Days |
| Rapid Recovery Group | Hospital Stay | 3.0 Days |
Comparison: Intention to Treat Analysisp-value: 0.36Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Day 0
Population: Measured in early patients only
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group (Standard Laparotomy) | Pain Assessment | 4.33 Score on a scale |
| Rapid Recovery Group | Pain Assessment | 3.13 Score on a scale |
p-value: 0.18Wilcoxon (Mann-Whitney)
Secondary
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.
Time frame: Post operative - day 2
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control Group (Standard Laparotomy) | Pain Medications Used | 10.0 Morphine equivalents |
| Rapid Recovery Group | Pain Medications Used | 7.5 Morphine equivalents |
Comparison: Intention to Treat Analysisp-value: 0.05Wilcoxon (Mann-Whitney)