Clinical trial · Interventional
Implementation of a Rapid Recovery Program in Gynecologic Oncology Surgery: A Pilot Study
NCT01705288CI-TRIAL-00043410completedEarly Phase 1Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterine Endometrial Cancer | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| intravenous narcotics | Drug | — | UNRESOLVED |
| Laparotomy | Procedure | — | UNRESOLVED |
| Non-steroidal anti-inflammatory drugs | Drug | — | UNRESOLVED |
| regional anesthesia | Drug | — | UNRESOLVED |
| standard anesthesia | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Control Group (Standard Laparotomy)
- description
- Patients undergoing standard anesthesia and standard exploratory laparotomy. Treatment will be per your surgeon's routine standards.
- interventionNames
- Procedure: Laparotomy
- Drug: intravenous narcotics
- Drug: standard anesthesia
- type
- EXPERIMENTAL
- label
- Rapid Recovery Group
- description
- 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.
- interventionNames
- Procedure: Laparotomy
- Drug: regional anesthesia
- Drug: Non-steroidal anti-inflammatory drugs
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (2)
- DERIVEDChau 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. PMID 35289396
- DERIVEDDickson 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. PMID 28079776