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NCT03577613 Clinical Trial

Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Surgery--Complications Clinical Trial

— RESurg  

Official title:
Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03577613
Other study ID # PR(AMI)23/1999
Secondary ID
Status Completed
Phase
First received
Last updated
Start date May 1, 1999
Est. completion date June 1, 2016

Study information
Verified date June 2018
Source Hospital Universitari Vall d'Hebron Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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 surgery (MIS): laparoscopic (LRH) or robotically assisted radical hysterectomy (RRH).

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).

Recruitment information / eligibility
Status Completed
Enrollment 188
Est. completion date June 1, 2016
Est. primary completion date June 1, 2016
Accepts healthy volunteers
Gender Female
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Open radical hysterectomy

• laparoscopic radical hysterectomy

• Robotically assisted radical hysterectomy

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Hospital Universitari Vall d'Hebron Research Institute

Outcome
Type Measure Description Time frame Safety issue
Primary Overall survival. From date of randomization until the date of death from any cause. up to 240 months
Secondary Disease free survival from surgery to time of recurrence or time of death(all causes) up to 240 months
Secondary Cancer specific survival from surgery to time of death( cervical cancer related) up to 240 month
Secondary surgical complication Rate Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 up to 28 days
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