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Completed

NCT Number: NCT03577613

Radical Hysterectomy: Evolution Of Surgical Approach and Related Outcomes

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).

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Key information

Conditions

Surgery--Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Open Radical Hysterectomy

Procedure

Laparoscopic Radical Hysterectomy

Procedure

Robotically assisted radical hysterectomy

Procedure

Primary outcomes

  1. Overall survival.

    Time frame: up to 240 months

    From date of randomization until the date of death from any cause.

Secondary outcomes

  1. Disease free survival

    Time frame: up to 240 months

    from surgery to time of recurrence or time of death(all causes)

  2. Cancer specific survival

    Time frame: up to 240 month

    from surgery to time of death( cervical cancer related)

  3. surgical complication Rate

    Time frame: up to 28 days

    Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Registry information

Acronym: RESurg

Important dates

Study start
1999
Primary completion
2016
Study completion
2016
First posted
Jul 5, 2018
Registry last updated
Jul 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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