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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01247779 |
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Date of registration:
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19/11/2010 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Perioperative Morbidity in Gyneco-oncology According to the Procedure : Coelioscopy Versus Robot-assisted Coelioscopy
ROBO-GYN |
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Scientific title:
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Assessment of Perioperative Morbidity in Gyneco-oncology According to the Surgical Approach : Coelioscopy Versus Robot-assisted Coelioscopy |
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Date of first enrolment:
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December 2010 |
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Target sample size:
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386 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01247779 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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France
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Contacts
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Name:
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Fabrice NARDUCCI, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Centre Oscar Lambret, Lille |
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Name:
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Eric LAMBAUDIE, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Institut Paoli-Calmettes |
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Ovarian Cancer
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Cervical Cancer
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Uterus Cancer
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Intervention(s)
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Procedure: gynecologic surgery - robot assisted coelioscopy
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Procedure: gynecologic surgery - standard coelioscopy
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Primary Outcome(s)
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Perioperative morbidity at six months
[Time Frame: six months after surgery]
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Secondary Outcome(s)
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Description of surgical procedures
[Time Frame: during surgery]
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Patient-reported survey of patient health
[Time Frame: until 2 years after surgery]
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Surgeon's ergonomy
[Time Frame: every hour during surgery (Borg scale), and at the end of intervention (NASA-TLX scale)]
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Anatomopathology
[Time Frame: during surgery]
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Anesthesic and ventilator parameters
[Time Frame: every 30 min during the surgery]
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Post-operative analgesia
[Time Frame: at 24h, 48h after sugery and until discharge]
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Progression-free survival
[Time Frame: until 2 years after surgery]
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Secondary ID(s)
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ROBOGYN - 1004
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2010-A00605-34
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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