NCT03577613

Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 188 (actual)
• Sponsor: Hospital Universitari Vall d'Hebron Research Institute · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: —

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).

Conditions

• Surgery--Complications

Interventions

Type	Name	Description
PROCEDURE	Open radical hysterectomy
PROCEDURE	laparoscopic radical hysterectomy
PROCEDURE	Robotically assisted radical hysterectomy

Timeline

• Start date: 1999-05-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2018-07-05
• Last updated: 2018-07-05