NCT03577613

Brief Summary

Prospective controlled study (Canadian Task Force II-2) : Comparison analysis regarding surgical outcomes, complications, overall survival (OS), disease free survival (DFS) and cancer specific survival between patients subjected to radical Hysterectomy either by open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 1999

Longer than P75 for all trials

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 1999

Completed
17.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

May 15, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
Last Updated

July 5, 2018

Status Verified

June 1, 2018

Enrollment Period

17.1 years

First QC Date

May 15, 2018

Last Update Submit

June 22, 2018

Conditions

Surgery--Complications

Keywords

radical hysterectomyminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • Overall survival.

    From date of randomization until the date of death from any cause.

    up to 240 months

Secondary Outcomes (3)

  • Disease free survival

    up to 240 months

  • Cancer specific survival

    up to 240 month

  • surgical complication Rate

    up to 28 days

Study Arms (3)

Early stage Cervical Cancer- Open Radical Hysterectomy(RH)

Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a open RH at our institution as primary treatment were included in the study

Procedure: Open radical hysterectomy

Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy

Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a laparoscopic RH at our institution as primary treatment were included in the study

Procedure: laparoscopic radical hysterectomy

Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH)

Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a robotically assisted RH at our institution as primary treatment were included in the study

Procedure: Robotically assisted radical hysterectomy

Interventions

Open radical hysterectomyPROCEDURE
Early stage Cervical Cancer- Open Radical Hysterectomy(RH)
laparoscopic radical hysterectomyPROCEDURE
Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy
Robotically assisted radical hysterectomyPROCEDURE
Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH)

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution

You may qualify if:

  • Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
  • Subjected to Radical Hysterectomy.

You may not qualify if:

  • Pregnant women in which a RH was performed at the time of caesarean section.
  • Previous chemotherapy treatment
  • Previous pelvic radiotherapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Antonio Gil-Moreno, MD, PhD

    Hospital Vall D'Hberon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2018

First Posted

July 5, 2018

Study Start

May 1, 1999

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 5, 2018

Record last verified: 2018-06