Clinical trial · Interventional
PONDER: Pelvic Peritonectomy in Early Stage Ovarian Tumors
Pelvic peritOnectomy iN Early Stage Ovarian Tumors: a prospEctive Study
- 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)
Early-stage ovarian tumors represent approximately 30% of all newly diagnosed ovarian cancers. Current international guidelines recommend random peritoneal biopsies for surgical staging, but the diagnostic yield of these biopsies remains limited. The PONDER study aims to evaluate whether standardized surgical procedure and pathology assessment of wider peritoneal pelvic biopsies can increase the detection rate of microscopic peritoneal implants and micrometastases in patients with early-stage ovarian tumors. This multicenter, prospective, single-arm study includes both minimally invasive and open surgical approaches, with a standardized gross and microscopic evaluation of the resected peritoneal specimens
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Ovarian Tumors | Ovarian Neoplasm | PROBABILISTIC | 0.70 |
| Peritoneal Carcinosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Histopathologic Analysis | Diagnostic Test | — | UNRESOLVED |
| systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Enrolled patients with FIGO 2018 IA-IB epithelial or non-epithelial ovarian/fallopian tube neoplasma
- description
- All patients will receive standard pre-, intra-, and postoperative care according to institutional guidelines. The peritonectomy procedure will not alter the choice of surgical access. Pelvic peritonectomy specimens will be analyzed as part of the final pathology report.
- interventionNames
- Procedure: systematic surgical approach to wider peritoneal biopsies according with dissection of retroperitoneal spaces, nerve-sparing approach
- Diagnostic Test: Histopathologic Analysis
Primary outcomes (1)
- measure
- Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants).
- timeFrame
- from surgery up to at least 24 months of follow up after surgery
- description
- Proportion of positive peritoneal biopsies after pelvic peritonectomy (detection of microscopic implants)
Secondary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years * FIGO 2018 stage IA-IB epithelial or non-epithelial ovarian or fallopian tube tumors * Complete preoperative work-up (ultrasound, CT scan, tumor markers) * Laparoscopic, robotic or open surgical approach * Signed informed consent Exclusion Criteria: * Sarcomas, melanomas, mesotheliomas, hematologic malignancies * Advanced ovarian tumors * Fertility-sparing surgery with uterine preservation * Inability to provide informed consent
References
Publications (1)
- RESULTvan de Vorst REWM, Hoogendam JP, van der Aa MA, Witteveen PO, Zweemer RP, Gerestein CG. The attributive value of comprehensive surgical staging in clinically early-stage epithelial ovarian carcinoma: A systematic review and meta-analysis. Gynecol Oncol. 2021 Jun;161(3):876-883. doi: 10.1016/j.ygyno.2021.04.007. Epub 2021 Apr 10. PMID 33849726