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Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy (ROBO-GYN)

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ClinicalTrials.gov Identifier: NCT01247779
Recruitment Status : Completed
First Posted : November 24, 2010
Last Update Posted : March 8, 2019
Sponsor:
Collaborators:
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
National Cancer Institute, France
Information provided by (Responsible Party):
Centre Oscar Lambret

Brief Summary:
The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.

Condition or disease Intervention/treatment Phase
Cervical Cancer Uterus Cancer Ovarian Cancer Procedure: gynecologic surgery - standard coelioscopy Procedure: gynecologic surgery - robot assisted coelioscopy Not Applicable

Detailed Description:

Laparoscopic surgery, also called minimally invasive surgery (MIS), is a surgical method less invasive than classical laparoscopic open procedure. Particularly, MIS is used for resection of some gynecological cancer such as endometrial cancer, cervical cancer or ovarian cancer. Several studies demonstrated that MIS induce less surgical complications (bleeding, infections, post-operative pains...), shorter hospitalization time, earlier recovery of activity and better quality of life than laparoscopic open procedure.

However, MIS is the selected method in only 9 to 25 % of gynecologic cancer surgery in France. This is likely due to the longer learning curve of MIS compared to laparoscopic open procedure.

In 2001 the FDA allowed the use of robot assisted laparoscopic surgery (RALS). This technique adds some advantage to laparoscopic surgery. Indeed, surgeon operates with better precision while seated comfortably at a computer console viewing a 3-D image of the surgical field. Moreover learning curve of RALS is shorter than MIS. Comparative studies between RALS and MIS demonstrate an equivalence of these techniques for operation length and bleeding. However for surgery linked complications and time for recovery of activity, RALS had better results than MIS.

Despite its expensive cost, RALS is now commonly used in North America (90% of prostatectomy and 40% of cancer linked hysterectomy). However RALS need to be evaluated in a randomized clinical trial before it's acceptation in gyneco-oncology in France.

Thus, the purpose of the ROBOGYN clinical trial is to compare clinical benefit of RALS and MIS in a randomized study for patients with cancer of cervix, uterus or ovary.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 386 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy
Actual Study Start Date : December 2010
Actual Primary Completion Date : March 2016
Actual Study Completion Date : November 2017


Arm Intervention/treatment
Active Comparator: Standard Coelioscopy
gynecologic surgery - standard coelioscopy
Procedure: gynecologic surgery - standard coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Experimental: Robot-assisted coelioscopy
gynecologic surgery - robot assisted coelioscopy
Procedure: gynecologic surgery - robot assisted coelioscopy
lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy




Primary Outcome Measures :
  1. Perioperative morbidity at six months [ Time Frame: six months after surgery ]
    To estimate the rate of complications within the first six months after surgery, according to the Clavien-Dindo and NCI CTCAE-v4.0 grading scales


Secondary Outcome Measures :
  1. Anesthesic and ventilator parameters [ Time Frame: every 30 min during the surgery ]
    Description of anesthesic and ventilator parameters

  2. Post-operative analgesia [ Time Frame: at 24h, 48h after sugery and until discharge ]
    collect of antalgic treatments

  3. Surgeon's ergonomy [ Time Frame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale) ]
    according to Borg and NASA-TLX scales

  4. Patient-reported survey of patient health [ Time Frame: until 2 years after surgery ]
    36-item short form health Survey (SF36) : Scoring is a two-step process. First, numeric values of all items are recoded per the scoring key (for example, values are 0/100, or 0/25/50/75/100 depending the items). All items are scored so that a high score defines a more favorable health state. Each item is scored on a 0 to 100 range so that the lowest and highest possible scores are 0 and 100, respectively. Scores represent the percentage of total possible score achieved. In step 2, items in the same scale are averaged together to create the 8 scale scores: physical functioning, Role functioning/physical, Role functioning/emotional, Energy/fatigue, Emotional well-being, Social functioning, Pain, General health, Health change. Scale scores represent the average for all items in the scale that the respondent answered.

  5. Description of surgical procedures [ Time Frame: during surgery ]
    operative time (overall intervention, incision or "skin-to-skin", robot).

  6. Progression-free survival [ Time Frame: until 2 years after surgery ]
    delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death.

  7. Anatomopathology [ Time Frame: during surgery ]
    rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient with uterus cancer depending on hysterectomy ± pelvic lymphadenectomy or a restadification
  • patient with cervical cancer depending on enlarged colpo-hysterectomy ± pelvic lymphadenectomy or a surgery after concomitant radiochemotherapy, or lombo aortic lymphadenectomy for a locally advanced cancer, or a restadification
  • patient with cervical cancer depending on a restadification
  • patient aged over 18 years
  • previous antitumor treatment allowed but necessarily disrupted 20 days before inclusion
  • WHO score equal or inferior to 3
  • cirrhosis-related Child-Pugh score under or equal to A7 are allowed
  • life expectancy equal or superior to 12 weeks
  • patient affiliated to health insurance
  • dated and signed informed consent

Exclusion Criteria:

  • metastatic disease
  • pregnant or breastfeeding woman
  • patient unable to proceed follow-up visit, because of geographic, social or mental reasons

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01247779


Locations
Show Show 17 study locations
Sponsors and Collaborators
Centre Oscar Lambret
CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie
National Cancer Institute, France
Investigators
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Principal Investigator: Fabrice NARDUCCI, MD Centre Oscar Lambret, Lille
Study Director: Eric LAMBAUDIE, MD Institut Paoli-Calmettes
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT01247779    
Other Study ID Numbers: ROBOGYN - 1004
2010-A00605-34 ( Other Identifier: IDRCB Number (ANSM_DEDIM) )
First Posted: November 24, 2010    Key Record Dates
Last Update Posted: March 8, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Oscar Lambret:
gynecology
oncology
coelioscopy
robot
morbidity
Additional relevant MeSH terms:
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Uterine Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Uterine Diseases