Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy

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

Detailed Description
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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.

Official Title
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Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy

Conditions
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Cervical Cancer, Uterus Cancer, Ovarian Cancer

Intervention / Treatment
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* Procedure: gynecologic surgery - standard coelioscopy
* Procedure: gynecologic surgery - robot assisted coelioscopy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Coelioscopy<br>gynecologic surgery - standard coelioscopy | Procedure: gynecologic surgery - standard coelioscopy<br>* lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy<br>|
| Experimental: Robot-assisted coelioscopy<br>gynecologic surgery - robot assisted coelioscopy | Procedure: gynecologic surgery - robot assisted coelioscopy<br>* lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perioperative morbidity at six months | 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 | six months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anesthesic and ventilator parameters | Description of anesthesic and ventilator parameters | every 30 min during the surgery | 
| Post-operative analgesia | collect of antalgic treatments | at 24h, 48h after sugery and until discharge | 
| Surgeon's ergonomy | according to Borg and NASA-TLX scales | every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale) | 
| Patient-reported survey of patient health | 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. | until 2 years after surgery | 
| Description of surgical procedures | operative time (overall intervention, incision or skin-to-skin, robot). | during surgery | 
| Progression-free survival | delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death. | until 2 years after surgery | 
| Anatomopathology | rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed. | during surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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oncology, gynecology, coelioscopy, robot, morbidity