Clinical trial · Observational
Uterine Manipulator in Endometrial Cancer Surgery: Pro MUCEI Study
A Prospective Study of the Impact of Uterine Manipulator on Oncological Outcome in Endometrial Cancer Surgery in Early-stage: Pro MUCEI 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)
The uterine manipulator is a device commonly used in minimally invasive hysterectomy surgery for endometrial cancer. However, without substantial evidence to support its use, surgeons are required to make decisions about its use based only on their personal choice and surgical experience. A retrospective study demonstrated how uterine manipulator use in early-stage endometrial cancer (FIGO I-II) for minimally invasive surgery was associated with a worse oncologic outcome in patients with uterus-confined endometrial cancer (FIGO I-II) who underwent minimally invasive surgery. The main objective of this study is to prospectively confirm the results obtained retrospectively, assessing the relapse rate in these patients related to the use or not of a uterine manipulator during the endometrial surgery. Secondary, the presence of risk factors that contraindicate the use of the uterine manipulator will also be evaluated.
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 |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| USE OF UTERINE MANIPULATOR DURING THE HYSTERECTOMY | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- uterine manipulator cohort
- description
- Patients with early-stage endometrial cancer who have performed a hysterectomy with a uterine manipulator to mobilize the uterus during the surgery.
- interventionNames
- Device: USE OF UTERINE MANIPULATOR DURING THE HYSTERECTOMY
- label
- no uterine manipulator cohort
- description
- Patients with early-stage endometrial cancer who have performed a hysterectomy without a uterine manipulator to mobilize the uterus during the surgery.
Primary outcomes (1)
- measure
- Relapse rate
- timeFrame
- 2 years
- description
- To prospectively evaluate the relapse rate in patients undergoing surgery for apparently early-stage endometrial cancer (FIGO I-II) with minimally invasive surgery with or without the use of a uterine manipulator.
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: 1. \- Women with endometrial cancer diagnosed with stage I-II. 2. \- Previous pre-surgical biopsy with a diagnosis of endometrial cancer. 3. \- The surgery has been performed and there are complete data on surgery, pathological anatomy, and follow-up of at least 2 years. Exclusion Criteria: * Any patient with suspected disease beyond the uterus in the preoperative assessment or confirmed during surgical exploration. Cases without pathological confirmation of endometrial cancer in the final surgical specimen or final histology of atypical hyperplasia/endometrial intraepithelial neoplasia will not be accepted. Patients with open surgery, conversion to laparotomy, or vaginal hysterectomy alone will also be excluded.
References
Publications (1)
- RESULTPadilla-Iserte P, Lago V, Tauste C, Diaz-Feijoo B, Gil-Moreno A, Oliver R, Coronado P, Martin-Salamanca MB, Pantoja-Garrido M, Marcos-Sanmartin J, Gilabert-Estelles J, Lorenzo C, Cazorla E, Roldan-Rivas F, Rodriguez-Hernandez JR, Sanchez L, Muruzabal JC, Hervas D, Domingo S; Spanish Society of Gynecology and Obstetrics Spanish Investigational Network Gynecologic Oncology Group. Impact of uterine manipulator on oncological outcome in endometrial cancer surgery. Am J Obstet Gynecol. 2021 Jan;224(1):65.e1-65.e11. doi: 10.1016/j.ajog.2020.07.025. Epub 2020 Jul 18. PMID 32693096