Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

gynecologic surgery - standard coelioscopy

gynecologic surgery - robot assisted coelioscopy

lymphadenectomy; hysterectomy; nerve sparing; enlarged trachelectomy; omentectomy; appendicectomy; pelvectomy

Fabrice NARDUCCI, MD

Eric LAMBAUDIE, MD

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

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.

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

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

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

Description of anesthesic and ventilator parameters

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.

operative time (overall intervention, incision or "skin-to-skin", robot).

delay between the date of randomization and the date of the following event: local relapse, regional relapse, metastasis or death.

rate of exeresis with histologically healthy resection margins (R0), number of lymph nodes removed.

CRG : Groupe Francophone de Chirurgie Robotique en Gynécologie

National Cancer Institute, France

Centre Oscar Lambret

Symptoms and General Pathology

Neoplastic Cells, Circulating

Uterine Cervical Diseases

Neoplasm Metastasis

Neoplastic Processes

Patients with cervical cancer eligible for surgery, stage IA1 to IB2

Peripheral blood samples at the beginning of surgery, after pneumoperitoneum creation and uterine pedicles coagulation.

Blood samples

Gauthier Rathat, MD

Martha Duraes, MD

Martha DURAES, MD

Gauthier RATHAT, MD

Sarah FRANCINI, MD

Pierre-Emmanuel COLOMBO, MD PhD

Pierre Emmanuel COLOMBO, MD PhD

Anne MOURREGOT, MD

Catherine FERRER, MD

Nathalie RUMEAU, CRA

Catherine MARSOLIER FERRER, MD

Renaud DE TAYRAC, MD PhD

Florent MASIA, MD

Cervical cancer is a rare pathology. Recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during different steps of the surgery.

The primary goal is to evaluate the spread of CTC during surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

CTC detection could be a pronostic factor for cancer evolution. Cervical cancer is a rare pathology with increased death rate.

Despite recommendations for coelioscopic treatment of \< 4cm cervical cancers, recent studies showed that the risk of recurrence is higher for patients treated by coelioscopy in comparison with laparotomy. It could be explained by the spread of circulating tumor cells (CTC) due to tumor mobilization during coelioscopic stadification and laparoscopic surgery.

Hypothesis : Mobilization of the tumor during coelioscopy leads to CTC spread. This spread could explain the recurrence of cervical cancer.

This pilot study will evaluate the possibility of CTC detection during surgery. The primary goal is to evaluate the spread of CTC during the different steps of surgery on peripheral blood samples.

The secondary outcome is to evaluation the disease-free survival at 3 and 5 years postoperatively.

20 patients with early stage cervical (IA1 to IB2) eligible to coelioscopic stadification and laparoscopic surgery will be included.

Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Preliminary Descriptive Exploratory Pilot Study Research of Circulating Tumor Cells Released During Cervical Cancer Surgery

Detection of the presence of at least one circulating tumor cell from blood samples taken during surgery (one CTC per 7.5mL of blood or increase of at least one CTC if CTC is present pre-operatively)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy	NCT01247779	Cervical Cancer Uterus Cancer Ovarian Cancer	gynecologic sur... gynecologic sur...	18 Years -	Centre Oscar Lambret
Research of Circulating Tumor Cells Released During Cervical Cancer Surgery	NCT04770090	Cervical Cancer... Cervical Cancer... Cervical Cancer... Cervical Cancer...	Blood samples	18 Years -	University Hospital, Montpellier

Spots Global Cancer Trial Database for coelioscopy

Every month we try and update this database with for coelioscopy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for coelioscopy

Every month we try and update this database with for coelioscopy cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for coelioscopy cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.