Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes (RESurg)
June 22, 2018 updated by: Hospital Universitari Vall d'Hebron Research Institute
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).
Study Overview
Status
Completed
Conditions
Detailed Description
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).
Study Type
Observational
Enrollment (Actual)
188
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
N/A
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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
|
|
|
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
|
|
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall survival.
Time Frame: up to 240 months
|
From date of randomization until the date of death from any cause.
|
up to 240 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Disease free survival
Time Frame: up to 240 months
|
from surgery to time of recurrence or time of death(all causes)
|
up to 240 months
|
|
Cancer specific survival
Time Frame: up to 240 month
|
from surgery to time of death( cervical cancer related)
|
up to 240 month
|
|
surgical complication Rate
Time Frame: up to 28 days
|
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
|
up to 28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Antonio Gil-Moreno, MD, PhD, Hospital Vall D'Hberon
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 1999
Primary Completion (Actual)
June 1, 2016
Study Completion (Actual)
June 1, 2016
Study Registration Dates
First Submitted
May 15, 2018
First Submitted That Met QC Criteria
June 22, 2018
First Posted (Actual)
July 5, 2018
Study Record Updates
Last Update Posted (Actual)
July 5, 2018
Last Update Submitted That Met QC Criteria
June 22, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- PR(AMI)23/1999
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.