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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Cervical Cancer, Uterus Cancer, Ovarian Cancer

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Trial Information

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


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 lactating woman

- patient unable to proceed follow-up visit, because of geographic, social or psychic
reasons

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Perioperative morbidity at six months

Outcome Description:

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

Outcome Time Frame:

six months after surgery

Safety Issue:

Yes

Principal Investigator

Fabrice NARDUCCI, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre Oscar Lambret, Lille

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

ROBOGYN - 1004

NCT ID:

NCT01247779

Start Date:

December 2010

Completion Date:

December 2015

Related Keywords:

  • Cervical Cancer
  • Uterus Cancer
  • Ovarian Cancer
  • gynecology
  • oncology
  • coelioscopy
  • robot
  • morbidity
  • Uterine Cervical Neoplasms
  • Ovarian Neoplasms
  • Uterine Neoplasms

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