Clinical trial · Observational
Effect of a Uterine Manipulator on the Incidence of Lymphovascular Propagation (LVSI) in Treatment of Endometrial Cancer
NCT05261165CI-TRIAL-00056811completedClinicalTrials.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)
We retrospectively analyzed data and compared the impact of intrauterine manipulators on incidence of LVSI in endometrial cancer patients treated at our department.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| LVSI | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| hysterectomy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- NonManip
- description
- In the group of female patients operated without a uterine manipulator (NonManip), we included the female patients who were operated by abdominal approach without no need to use a manipulator. These female patients did not meet the predominantly anesthesiological requirements for the tolerance of the Trendelenburg position; respectively, the likelihood of adhesions in the abdominal cavity after previous laparotomy operations was there. Therefore, from a safety point of view, due to the risk of damage to the abdominal organs and the need for extensive adhesiolysis, the primary endoscopic surgery was not performed.
- interventionNames
- Procedure: hysterectomy
- label
- Manip
- description
- The female patients suitable for endoscopic performance to laparoscopic, respectively the robotic hysterectomies, in whom the use of a uterine manipulator (Manip) was planned, were assigned random into two groups.
- interventionNames
- Procedure: hysterectomy
- label
- ManipHe
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * endometrioid endometrial cancer, * planned primary surgical treatment - hysterectomy, * medical condition enabling anesthesia and surgery, * pre-surgical clinically-determined affecting of the uterine according to MRI or ultrasound - cT1a or cT1b Exclusion Criteria: * non-endometrioid type of tumor in definitive histology, * stage 2 of a disease and higher, * previous chemo or radiotherapy, * inability to adequately complete the surgery, * uterine perforation during surgery
References
Publications (1)
- DERIVEDHudec B, Dokus K, Urdzik P, Skolka R, Konarcikova T, Smitka M. Influence of uterine manipulator use on the incidence of lymphovascular propagation in the treatment of endometrial cancer. Minim Invasive Ther Allied Technol. 2023 Feb;32(1):12-17. doi: 10.1080/13645706.2022.2153342. Epub 2022 Dec 21. PMID 36542513