Robotic-assisted Versus Conventional Laparoscopic Surgery in Obese Patients With Early Endometrial Cancer

NCT05974995RecruitingNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

566

Start Date

2023-09-01

Completion Date

2026-09-01

Study Type

INTERVENTIONAL

Official Title

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

Interventions

Robot-assisted surgeryLaparoscopic surgery

Conditions

Endometrial CancerEndometrial NeoplasmsObesityMorbidGynecologic CancerGynecologic Disease

Eligibility

Age Range

18 Years – 75 Years

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Conversion rate

Number of procedures converted to laparotomy from MIS

Time frame: At the end of the enrollment phase

Secondary Outcomes

Difference in overall duration of surgery

Difference in duration of procedures measured in minutes

Time frame: At the end of the enrollment phase

Difference in perioperative complications

Number of patients with at least one perioperative complications measured by Clavien Dindo

Time frame: 36 and 72 months

Adherence to sentinel lymph node MSKCC algorithm

Number of case with completed lymph nodal staging according to MSKCC algorithm

Time frame: At the end of the enrollment phase

Ergonomics of the two different surgical approach

Investigators will evaluate the ergonomics of the two MIS system through the Rapid Upper Limb Assessment (RULA) assessment tool. Rula is aimed to make a rapid assessment on neck and upper limb loading in tasks. The risk of work-related disorders is calculated into a score of 1(low) to 7 (high)

Time frame: 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

Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire will be used. The Functional Assessment of Cancer Therapy - General (FACT-G) is a 27-item questionnaire designed to measure physical, social, emotional, and functional well-being in cancer patients. The score range 0-108; the higher the score, the better the QOL.

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

Adherence to ESGO surgical Quality Index

Investigators will assess adherence to ESGO surgical Quality Index (QI, rate of uterine rupture)

Time frame: 36 and 72 months

Difference in overall survival and disease-free survival

Investigators will evaluate difference in Overall Survival, defined as the time between randomization and death for any cause, for alive patients OS will be censored at the date of last follow-up; investigators will evaluate difference in disease-free survival, defined as the time between randomization and the first detection of relapse or death, whichever event occurs first; for patients without events DFS will be censored at the date of last follow-up

Time frame: 36 and 72 months

Locations

Policlinico Gemelli IRCCS, Rome, Italy

Linked Diseases

Endometrial Neoplasms

Endometrial Neoplasms — a type of gynecological cancer.

Linked Papers

2024-05-06

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)

Nearly 65% of patients with endometrial cancer who undergo primary hysterectomy have concurrent obesity. Retrospective data show advantages in using robotic surgery in these patients compared with conventional laparoscopy, namely lower conversion rate, increased rate of same-day discharge, and reduced blood loss. Nevertheless, to date no prospective randomized controlled trials have compared laparoscopic surgery versus robotic-assisted surgery in morbidly obese patients. The 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) trial aims to find the most appropriate minimally invasive surgical approach in morbidly obese patients with endometrial carcinoma. Robotic surgery will reduce conversions to laparotomy in endometrial cancer patients with obesity compared with those who undergo surgery with conventional laparoscopy. This phase III multi-institutional study will randomize consecutive obese women with apparent early-stage endometrial cancer to either laparoscopic or robot-assisted surgery. The RObese trial will include obese (BMI≥30 kg/m Conversion rate to laparotomy between laparoscopic surgery versus robot-assisted surgery. RObese is a superiority trial. The clinical superiority margin for this study is defined as a difference in conversion rate of -6%. Assuming a significance level of 0.05 and a power of 80%, the study plans to randomize 566 patients. Patient recruitment will be completed by 2026, and follow-up will be completed by 2029 with presentation of data shortly thereafter. Two interim analyses are planned: one after the first 188 and the second after 376 randomized patients. NCT05974995.

Linked Investigators

Anna Fagotti

Denis Querleu

Francesco Fanfani

Giorgia Dinoi

Giovanni Scambia

Ilaria Capasso

Nicolò Bizzarri