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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group (Standard Laparotomy) | Active Comparator | Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards. |
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| Rapid Recovery Group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Laparotomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 Month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Post operative - day 2 |
| Pain Assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Peter Argenta, M.D. | Masonic Cancer Center, University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Masonic Cancer Center, University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35289396 | Derived | 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. | |
| 28079776 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| intravenous narcotics | Drug | given for pain management after surgery per physician orders |
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| standard anesthesia | Drug | inhalant or intravenous during surgery |
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| regional anesthesia | Drug | given by spinal or epidural infusion |
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| Non-steroidal anti-inflammatory drugs | Drug | given for pain management after surgery |
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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.
| Day 0 |
| FG001 | 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 |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| 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 | Individuals randomized who underwent eligible surgery | Posted | Median | 95% Confidence Interval | Days | 1 Month |
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| 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. | Posted | Median | 95% Confidence Interval | Morphine equivalents | Post operative - day 2 |
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| 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. | Measured in early patients only | Posted | Median | 95% Confidence Interval | Score on a scale | Day 0 |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 1 | 52 | 4 | 52 | ||
| EG001 | 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 | 4 | 51 | 7 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ICU admission | General disorders | Systematic Assessment | The reason behind ICU admission is not recorded/details not available |
| |
| Hemorrhage | Blood and lymphatic system disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Individual adverse events breakup not known | General disorders | Systematic Assessment | Only the counts of adverse events were available. The details of each adverse events data not available |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Peter Argenta | Masonic Cancer Center at University of Minnesota | 612-626-6283 | argenta@umn.edu |
| ID | Term |
|---|---|
| D002583 | Uterine Cervical Neoplasms |
| D016889 | Endometrial Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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| ID | Term |
|---|---|
| D007813 | Laparotomy |
| D009020 | Morphine |
| D000768 | Anesthesia, General |
| D000765 | Anesthesia, Conduction |
| D000772 | Anesthesia, Local |
| D000894 | Anti-Inflammatory Agents, Non-Steroidal |
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D009022 | Morphine Derivatives |
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
| D018712 | Analgesics, Non-Narcotic |
| D000700 | Analgesics |
| D018689 | Sensory System Agents |
| D018373 | Peripheral Nervous System Agents |
| D045505 | Physiological Effects of Drugs |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D000893 | Anti-Inflammatory Agents |
| D045506 | Therapeutic Uses |
| D018501 | Antirheumatic Agents |
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| >=65 years |
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| Male |
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