Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes (RESurg)

Vall d'Hebron University Hospital (HUVH)

Status: Completed

Conditions: Surgery--Complications

Treatments: Procedure: Open radical hysterectomy; Procedure: Robotically assisted radical hysterectomy; Procedure: laparoscopic radical hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT03577613

PR(AMI)23/1999

Details and patient eligibility

About

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).

Full 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).

Enrollment: 188 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

188 participants in 3 patient groups

Early stage Cervical Cancer- Open Radical Hysterectomy(RH)

Description:

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

Treatment:

Procedure: Open radical hysterectomy

Early stage Cervical Cancer- Laparoscopic Radical Hysterectomy

Description:

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

Treatment:

Procedure: laparoscopic radical hysterectomy

Early stage Cervical Cancer- Robotic radical Hysterectomy(RRH)

Description:

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

Treatment:

Procedure: Robotically assisted radical hysterectomy