Surgery--ComplicationsRESurgNCT03577613
Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes
An observational study of Surgery--Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Open radical hysterectomy, laparoscopic radical hysterectomy and Robotically assisted radical hysterectomy
- Type of treatment
- Surgery or procedure
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 1 May 1999to 1 Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Adult, Older adult
Study population: Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution
Who may be able to join
- Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
- Subjected to Radical Hysterectomy.
Who cannot join
- Pregnant women in which a RH was performed at the time of caesarean section.
- Previous chemotherapy treatment
- Previous pelvic radiotherapy
About this study
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).
Read the 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).
- Conditions
- Surgery--Complications
- Being tested
- Open radical hysterectomy, laparoscopic radical hysterectomy, Robotically assisted radical hysterectomy
- Keywords
- radical hysterectomy, minimally invasive surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open radical hysterectomyProcedure or surgery
laparoscopic radical hysterectomyProcedure or surgery
Robotically assisted radical hysterectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Procedure: Robotically assisted radical hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival.
From date of randomization until the date of death from any cause.
Measured: up to 240 months
Secondary outcomes (3)
Disease free survival
from surgery to time of recurrence or time of death(all causes)
Measured: up to 240 months
Cancer specific survival
from surgery to time of death( cervical cancer related)
Measured: up to 240 month
surgical complication Rate
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start1 May 1999
- Primary completion1 Jun 2016
- Study completion1 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Gil-Moreno, MD, PhD, Principal investigator, Hospital Vall D'Hberon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577613
- Sponsor's protocol ID
- PR(AMI)23/1999
- Acronym
- RESurg
- Status last verified
- Jun 2018
- First submitted
- 15 May 2018
- Last updated
- 5 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes
- ClinicalTrials.gov ID
- NCT03577613
- Acronym / sponsor ID
- RESurg / PR(AMI)23/1999
- Conditions
- Surgery--Complications
- Keywords
- radical hysterectomy, minimally invasive surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 May 1999 (actual)
- Primary completion
- 1 Jun 2016 (actual)
- Study completion
- 1 Jun 2016 (actual)
- First posted
- 5 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Early stage Cervical Cancer- Open Radical Hysterectomy(RH) | – | Procedure: Open radical hysterectomyPatients 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 | – | Procedure: laparoscopic radical hysterectomyPatients 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) | – | Procedure: Robotically assisted radical hysterectomyPatients 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Patients who were clinically diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer and underwent a RH at our institution
Key inclusion criteria (2 listed)
- Patients diagnosed with FIGO stage IA2-IB1-IIA1 cervical cancer.
- Subjected to Radical Hysterectomy.
Key exclusion criteria (3 listed)
- Pregnant women in which a RH was performed at the time of caesarean section.
- Previous chemotherapy treatment
- Previous pelvic radiotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open radical hysterectomy | Procedure or surgery | Early stage Cervical Cancer- Open Radical Hysterectomy(RH) |
| laparoscopic radical hysterectomy | Procedure or surgery | Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy |
| Robotically assisted radical hysterectomy | Procedure or surgery | Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH) |
Primary outcome
Overall survival.
Time frame: up to 240 months
From date of randomization until the date of death from any cause.
3 secondary outcomes
Disease free survival
Time frame: up to 240 months
Cancer specific survival
Time frame: up to 240 month
surgical complication Rate
Time frame: up to 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Surgery--Complications
Not yet recruitingObservational study
Systematic Intraoperative Cell Salvage in On-Pump Cardiac Surgery Within a Mature Patient Blood Management Programme
Cardiac Surgical Procedures, Blood Transfusion
Recruiting
Change in Platelet Lipid Metabolism and Procoagulant Phenotype Induced by Cardiopulmonary Bypass. Impact on Postoperative Inflammatory Response and Bleeding Complications During Cardiac Surgery.
Cardiac Surgery, Cardiopulmonary Bypass
Recruiting
A Study to Compare Two Surgical Procedures in Individuals With BRCA1 Mutations to Assess Reduced Risk of Ovarian Cancer
Ovarian Carcinoma
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Recruiting
Prospective, Multicenter, Randomized Controlled Phase III Trial of Biological Mesh for Alimentary Tract Reconstruction in Digestive Surgery
Digestive System Surgical Procedures, Anastomosis, Surgical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Gil-Moreno, MD, PhD principal investigator
Hospital Vall D'Hberon
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery--Complications, run by Hospital Universitari Vall d'Hebron Research Institute.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival. (time frame: up to 240 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2018.