NCT02762214

Brief Summary

Prospective multicentric randomized trial to evaluate the role of uterine manipulator on laparoscopic/robotic total hysterectomy for the treatment of early stage G1 - G2 endometrial cancer (International Federation of Gynecology and Obstetrics - FIGO stages IA-IB).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
154

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Oct 2015

Geographic Reach
1 country

1 active site

Status
unknown

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 Start

First participant enrolled

October 1, 2015

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
Last Updated

May 4, 2016

Status Verified

May 1, 2016

Enrollment Period

1 year

First QC Date

April 16, 2016

Last Update Submit

May 2, 2016

Conditions

Endometrial Cancer

Keywords

Uterin manipulatorEndometrial CancerLaparoscopyRobotic

Outcome Measures

Primary Outcomes (1)

  • Upstaging rate

    Evaluation of Lymphovascular space invasion and pre- / post-Hysterectomy pelvic cytology in order to investigate if the use of uterine manipulator has a role in upstaging of early-stage endometrial cancer

    30 days

Secondary Outcomes (6)

  • Complications

    within 30 days from surgery

  • Blood Loss

    Intraoperative

  • Impact of surgical procedure

    Perioperative

  • Role of uterine manipulator in Obesity

    Intraoperative

  • Impact on postoperative pain

    Postoperative

  • +1 more secondary outcomes

Study Arms (2)

With Uterine Manipulator

ACTIVE COMPARATOR

77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer using uterine manipulator.

Device: Clermont-Ferrand Uterine Manipulator

Without Uterine Manipulator

EXPERIMENTAL

77 Patients affected by early stage endometrial cancer submitted to elective laparoscopic/robotic hysterectomy for endometrial cancer without support of uterine manipulator.

Other: No uterine Manipulator

Interventions

Clermont-Ferrand Uterine ManipulatorDEVICE

Pelvic cytology is obtained before starting surgical procedures (washing number 1). After tubal coagulation, Clermont-Ferrand Uterine Manipulator is installed inside the uterus. At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)

With Uterine Manipulator
No uterine ManipulatorOTHER

Pelvic cytology is obtained before starting surgical procedures (washing number 1). None uterine manipulator is used and the cervix is closed with a cross stitch. Tubal coagulation, At the end of the hysterectomy, after colporrhaphy, a second cytology is obtained (washing number 2)

Without Uterine Manipulator

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • For patients
  • Age \> 18 \< 80 years
  • Patient's informed consent
  • American Society of Anesthesiologists: \< class III or IV
  • No actual pregnancies
  • Body Mass Index (BMI) ≤ 35
  • For diseases
  • Early stage endometrial cancer (IA-IB)
  • Endometrioid histotype (G1-G2)

You may not qualify if:

  • For patients
  • Age \> 18 \< 80
  • Actual pregnancies
  • Previous gynecological cancer
  • For disease
  • Type II endometrial cancer histotype
  • Grade 3 endometrial cancer
  • Advanced stage endometrial cancer (II - IV)
  • Previous radiotherapy on the pelvic field
  • Uterine size larger than conform 12 weeks gestation or 9 cm in horizontal
  • Necessity of laparotomic procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Oncologic Gynecology, Fondazione Policlinico Gemelli

Rome, Rome, 00168, Italy

RECRUITING

MeSH Terms

Conditions

Endometrial Neoplasms

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 16, 2016

First Posted

May 4, 2016

Study Start

October 1, 2015

Primary Completion

October 1, 2016

Study Completion

October 1, 2017

Last Updated

May 4, 2016

Record last verified: 2016-05

Locations

IT(1)