An Early Phase 1 interventional study of Laparotomy and intravenous narcotics in Cervical Cancer, Uterine Endometrial Cancer and Ovarian Cancer, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-02-17.
Sponsored by Masonic Cancer Center, University of Minnesota · Early Phase 1, Interventional, and Supportive care
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).
1,325 studies on the registry are indexed under Endometrial Neoplasms; 447 are open to participants now.
This study's enrollment of 103 is above the median of 70 across 941 interventional studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
Procedure: Laparotomy · Drug: intravenous narcotics · Drug: standard anesthesia
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.
Procedure: Laparotomy · Drug: regional anesthesia · Drug: Non-steroidal anti-inflammatory drugs
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
Also known as: morphine
inhalant or intravenous during surgery
Also known as: general anesthesia
given by spinal or epidural infusion
Also known as: local anesthesia
given for pain management after surgery
Also known as: NSAIDs
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
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
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
| Milestone | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| Started | 52 | 51 |
| Completed | 52 | 51 |
| Not completed | 0 | 0 |
Length of hospital stay for patients undergoing laparotomy on the gynecologic oncology service measured as whole days from the day of surgery until discharge
| Days | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| Hospital Stay | 3.0 (2.0 to 3.0) | 3.0 (2.0 to 3.0) |
Total daily narcotic pain medication used by patients. Narcotic use was standardized by conversion to morphine equivalents using the methods of Korff et al.
| Morphine equivalents | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| Pain Medications Used | 10.0 (8.3 to 12.3) | 7.5 (3.3 to 10.0) |
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.
| Score on a scale | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| Pain Assessment | 4.33 (3.0 to 6.25) | 3.13 (2.30 to 4.40) |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Control Group (Standard Laparotomy) | — | 1/52 (1.9%) | 4/52 (7.7%) |
| Rapid Recovery Group | — | 4/51 (7.8%) | 7/51 (13.7%) |
| Event | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| ICU admissionGeneral disorders | 1/52 | 3/51 |
| HemorrhageBlood and lymphatic system disorders | 0/52 | 1/51 |
| Event | Control Group (Standard Laparotomy) | Rapid Recovery Group |
|---|---|---|
| Individual adverse events breakup not knownGeneral disorders | 4/52 | 7/51 |
| Age, Categorical(Participants) | Control Group (Standard Laparotomy) | Rapid Recovery Group | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 52 | 51 | 103 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Control Group (Standard Laparotomy) | Rapid Recovery Group | Total |
|---|---|---|---|
| Median | 56.0 (52.8 to 59.2) | 55.4 (52.3 to 58.5) | 55.65 (52.8 to 58.5) |
| Sex: Female, Male(Participants) | Control Group (Standard Laparotomy) | Rapid Recovery Group | Total |
|---|---|---|---|
| Female | 52 | 51 | 103 |
| Male | 0 | 0 | 0 |
| Region of Enrollment(participants) | Control Group (Standard Laparotomy) | Rapid Recovery Group | Total |
|---|---|---|---|
| United States | 52 | 51 | 103 |
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Masonic Cancer Center, University of Minnesota