Early Phase 1
N=103
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
Cervical Cancer · Uterine Endometrial Cancer · Ovarian Cancer
Bottom Line
View on ClinicalTrials.gov: NCT01705288 ↗Enrolled (actual)
103
Serious AEs
4.9%
Results posted
Feb 2020
Primary outcome: Primary: Hospital Stay — 3.0; 3.0 Days — p=0.36
Study Design & Population
- Study type
- Interventional
- Phase
- Early Phase 1
- Interventions
- Laparotomy (Procedure); intravenous narcotics (Drug); standard anesthesia (Drug); regional anesthesia (Drug); Non-steroidal anti-inflammatory drugs (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Masonic Cancer Center, University of Minnesota
- Primary completion
- Aug 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Hospital Stay |
3.0; 3.0 | 0.36 |
| SECONDARY Pain Medications Used |
10.0; 7.5 | 0.05 |
| SECONDARY Pain Assessment |
4.33; 3.13 | 0.18 |
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.
Eligibility Criteria
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
- or = 3
- Any condition that would exclude women from undergoing regional anesthesia
Data sourced from ClinicalTrials.gov (NCT01705288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.