Clinical trial · Interventional
Perioperative Risk Study
A Randomized Controlled Trial of Perioperative Risk Stratification and Risk-based, Protocol-driven Management in Patients Undergoing Elective Major Cancer Surgery
NCT02456389CI-TRIAL-00088107PRSactive not recruitingN/AClinicalTrials.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)
The primary objective of this trial is to determine if perioperative risk stratification and risk-based, protocol-driven management leads to a reduction in the rate of death or serious complications compared to standard perioperative management in patients undergoing elective major cancer surgery.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Primary Neoplasm | Primary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Secondary Neoplasm | Secondary Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Surgery | — | UNRESOLVED | — |
| Tumors | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Postoperative risk stratification | Other | — | UNRESOLVED |
| Preoperative risk stratification | Other | — | UNRESOLVED |
| Risk-based, escalating levels of care | Other | — | UNRESOLVED |
| Risk-based, escalating levels of co-management | Other | — | UNRESOLVED |
| Risk-based, escalating levels of monitoring | Other | — | UNRESOLVED |
| Standard postoperative care | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard perioperative management
- description
- Standard postoperative care
- interventionNames
- Other: Standard postoperative care
- type
- EXPERIMENTAL
- label
- Risk-based, perioperative management
- description
- Preoperative risk stratification Postoperative risk stratification Risk-based, escalating levels of care Risk-based, escalating levels of monitoring Risk-based, escalating levels of co-management
- interventionNames
- Other: Preoperative risk stratification
- Other: Postoperative risk stratification
- Other: Risk-based, escalating levels of care
- Other: Risk-based, escalating levels of monitoring
- Other: Risk-based, escalating levels of co-management
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
INCLUSION CRITERIA: 1. Age \> or = 18 years at diagnosis. 2. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, 2, or 3. 3. Probable (i.e., clinically suspicious) or histologically/cytologically confirmed, primary or recurrent, malignant neoplasm, malignant neuroendocrine tumor, or carcinoma in situ (any stage). 4. Scheduled for curative or palliative major cancer surgery, including: * Glossectomy * Pharyngectomy * Laryngectomy * Neck dissection * Esophagectomy * Lung resection * Gastrectomy * Pancreatectomy * Hepatectomy * Colectomy * Proctectomy * Hysterectomy/Myomectomy * Gynecologic reconstruction * Prostatectomy * Nephrectomy * Cystectomy * Breast reconstruction * Flap reconstruction 5. Scheduled for elective major cancer surgery at Fox Chase Cancer Center within 30 days after First Registration. 6. Ability to understand and willingness to sign a written informed consent and Health Insurance Portability and Accountability Act (HIPAA) consent document 7. Geographical accessibility and willingness to return to Fox Chase Cancer Center for all preoperative and postoperative study assessments. EXCLUSION CRITERIA: 1. Clinical or tissue diagnosis of benign neuroendocrine tumor, benign neoplasm, neoplasm of uncertain behavior, or neoplasm of unspecified nature. 2. Use of systemic chemotherapy and/or radiation therapy \< 14 days prior to First Registration. Palliative radiation therapy is permitted for irradiating small areas of painful bony metastases that cannot be managed adequately using systemic or local analgesics 3. Any condition that might interfere with the subject's participation in the study, compliance with study requirements, or in the evaluation of the study results.
References
Publications (0)
Data not yet available
No reference posted for this study.