Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

Completed

• Conditions: Surgery--Complications

• Registration Number: NCT03577613
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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).

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 Timeline

• Study Start: 1999-05-01
• Primary Completion: 2016-06-01
• Study Completion: 2016-06-01
• Study First Submitted: 2018-05-15
• Status Verified: 2018-06
• Study First Submitted QC: 2018-06-22
• Last Update Submitted: 2018-06-22
• Study First Posted: 2018-07-05
• Last Update Posted: 2018-07-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 188

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall survival.	up to 240 months	From date of randomization until the date of death from any cause.

Secondary Outcome Measures

Name	Time	Method
surgical complication Rate	up to 28 days	Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
Disease free survival	up to 240 months	from surgery to time of recurrence or time of death(all causes)
Cancer specific survival	up to 240 month	from surgery to time of death( cervical cancer related)