NCT05974995

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
566

participants targeted

Target at P75+ for not_applicable

Timeline
40mo left

Started Sep 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress45%
Sep 2023Sep 2029

First Submitted

Initial submission to the registry

July 18, 2023

Completed
16 days until next milestone

First Posted

Study publicly available on registry

August 3, 2023

Completed
29 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2029

Last Updated

October 3, 2024

Status Verified

October 1, 2024

Enrollment Period

3 years

First QC Date

July 18, 2023

Last Update Submit

October 1, 2024

Conditions

Endometrial CancerEndometrial NeoplasmsObesity, MorbidGynecologic CancerGynecologic Disease

Outcome Measures

Primary Outcomes (1)

  • Conversion rate

    Number of procedures converted to laparotomy from MIS

    At the end of the enrollment phase

Secondary Outcomes (7)

  • Difference in overall duration of surgery

    At the end of the enrollment phase

  • Difference in perioperative complications

    36 and 72 months

  • Adherence to sentinel lymph node MSKCC algorithm

    At the end of the enrollment phase

  • Ergonomics of the two different surgical approach

    At the end of the enrollment phase

  • Quality of life (QoL) at baseline, 1 and 4 weeks (early), and 3 and 6 months (late) after surgery

    1 and 4 weeks (early), and 3 and 6 months (late) after surgery

  • +2 more secondary outcomes

Study Arms (2)

Robotic surgery

EXPERIMENTAL
Procedure: Robot-assisted surgery

Laparoscopic surgery

ACTIVE COMPARATOR
Procedure: Laparoscopic surgery

Interventions

Robot-assisted surgeryPROCEDURE

Total hysterectomy with bilateral salpingo-oophorectomy and lymphnodes staging using DaVinci Xi

Robotic surgery
Laparoscopic surgeryPROCEDURE

Total hysterectomy with bilateral salpingo-oophorectomy and lymph nodes staging using standard laparoscopic approach

Laparoscopic surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico Gemelli IRCCS

Rome, 00167, Italy

RECRUITING

Related Publications (1)

  • Dinoi 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: 38326228DERIVED

MeSH Terms

Conditions

Endometrial NeoplasmsObesity, MorbidGenital Diseases, Female

Interventions

Robotic Surgical ProceduresLaparoscopy

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Surgery, Computer-AssistedSurgical Procedures, OperativeRoboticsAutomationTechnologyTechnology, Industry, and AgricultureEndoscopyDiagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical Procedures

Study Officials

  • Francesco Fanfani, MD

    Policlinico Gemelli IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Fanfani, MD

CONTACT

0630153421francesco.fanfani@policlinicogemelli.it

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 18, 2023

First Posted

August 3, 2023

Study Start

September 1, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2029

Last Updated

October 3, 2024

Record last verified: 2024-10

Locations

IT(1)