Clinical trial · Interventional
Regional Anesthesia and Endometrial Cancer Recurrence
NCT00531349CI-TRIAL-00022047ECA/RwithdrawnPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of study population
Summary
Brief summary (as posted)
The purpose of this study is to determine whether recurrence of local and metastatic cancer after open hysterectomy for stage 1 or 2 endometrial cancer is reduced when patients receive epidural anesthesia/analgesia combined with propofol sedation rather than sevoflurane anesthesia and opioid analgesia.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| propofol general anesthesia | Procedure | — | UNRESOLVED |
| Sevoflurane | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- A
- description
- General anesthesia and opioid analgesia for the treatment of pain after surgery.
- interventionNames
- Drug: Sevoflurane
- type
- ACTIVE_COMPARATOR
- label
- B
- description
- Regional anesthesia and analgesia (epidural) combined with deep sedation or general anesthesia.
- interventionNames
- Procedure: propofol general anesthesia
Primary outcomes (1)
- measure
- Time to metastatic spread or local cancer recurrence
- timeFrame
- every six months throughout the study, yearly thereafter
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: 1. Primary endometrial cancer without known extension beyond the uterus i.e., believed to be Stage 1 or 2 2. Scheduled for open abdominal hysterectomy 3. Written informed consent, including willingness to be randomized epidural anesthesia/analgesia with sedation or to sevoflurane general anesthesia and postoperative opioid analgesia Exclusion Criteria: 1. Previous surgery for endometrial cancer 2. Any contraindication to epidural anesthesia or analgesia (including coagulopathy, abnormal anatomy) 3. Any contraindication to midazolam, propofol, sevoflurane, fentanyl, or morphine 4. Age \< 18 or \> 85 years old 5. ASA Physical Status ≥ 4 6. Any contraindication to epidural anesthesia and analgesia (including coagulopathy, abnormal anatomy) 7. Other cancer not believed by the attending surgeon to be in long-term remission 8. Systemic disease believed by the attending surgeon or anesthesiologist to present ≥ 25% two-year mortality
References
Publications (0)
Data not yet available
No reference posted for this study.