Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

NCT ID: NCT03577613

Last Updated: 2018-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

188 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-05-01

Study Completion Date

2016-06-01

Brief Summary

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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).

Detailed Description

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Study Objective: To analyse the effect that the introduction of minimally invasive procedures has had on surgical and oncological outcomes when compared with conventional open radical hysterectomy (ORH) in a national reference cancer center Design: A prospective controlled study (Canadian Task Force II-2) Setting: A university teaching hospital Patients: All patients that underwent RH as primary treatment for cervical cancer in our institution between May 1999 and June 2016, with a total of 188 patients.

Interventions: Patients underwent an open radical hysterectomy (ORH) or minimally invasive surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

Conditions

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Surgery--Complications

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Open radical hysterectomy

Intervention Type PROCEDURE

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

laparoscopic radical hysterectomy

Intervention Type PROCEDURE

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

Robotically assisted radical hysterectomy

Intervention Type PROCEDURE

Interventions

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Open radical hysterectomy

Intervention Type PROCEDURE

laparoscopic radical hysterectomy

Intervention Type PROCEDURE

Robotically assisted radical hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Hospital Universitari Vall d'Hebron Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonio Gil-Moreno, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall D'Hberon

Other Identifiers

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PR(AMI)23/1999

Identifier Type: -

Identifier Source: org_study_id

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