Clinical trial · Interventional
Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer
Robotic-assisted Versus Conventional Laparoscopic Surgery in the Management of Obese Patients With Early Endometrial Cancer in the Sentinel Lymph Node Era: a Randomized Controlled 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)
Data across literature suggest that robotic surgery may offer benefit specifically in patient with morbid obesity with endometrial cancer, but to date no randomized trials have been conducted to confirm these observations. This randomized controlled multicentric trial aims to evaluate the most appropriate minimally invasive surgical approach in morbidly obese (BMI \>= 30) patients with endometrial carcinoma.
Conditions
Conditions (5)
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 |
| Endometrial Neoplasms | Endometrial Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Disease | — | UNRESOLVED | — |
| Obesity, Morbid | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Laparoscopic surgery | Procedure | — | UNRESOLVED |
| Robot-assisted surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Robotic surgery
- interventionNames
- Procedure: Robot-assisted surgery
- type
- ACTIVE_COMPARATOR
- label
- Laparoscopic surgery
- interventionNames
- Procedure: Laparoscopic surgery
Primary outcomes (1)
- measure
- Conversion rate
- timeFrame
- At the end of the enrollment phase
- description
- Number of procedures converted to laparotomy from MIS
Secondary outcomes (7)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * BMI \>=30 * Age \> 18 * Histologically confirmed endometrioid endometrial cancer * Clinical early stage (stage I) * No contraindication for minimally invasive surgery * ASA\<4 * Written informed consent. Exclusion Criteria: * High probability of laparotomy related to uterine volume (US estimated weight \>250 g) * Concomitant pelvic disease, or anatomical characteristics of the patient * (Use of uterine manipulator) * Age \>75 years
References
Publications (1)
- DERIVEDDinoi G, Tarantino V, Bizzarri N, Perrone E, Capasso I, Giannarelli D, Querleu D, Giuliano MC, Fagotti A, Scambia G, Fanfani F. Robotic-assisted versus conventional laparoscopic surgery in the management of obese patients with early endometrial cancer in the sentinel lymph node era: a randomized controlled study (RObese). Int J Gynecol Cancer. 2024 May 6;34(5):773-776. doi: 10.1136/ijgc-2023-005197. PMID 38326228