Clinical trial · Interventional
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
NCT01247779CI-TRIAL-00105426ROBO-GYNcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare perioperative morbidity of coelioscopy versus robot-assisted coelioscopy in cervical cancer, uterus cancer and ovarian cancer.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Uterus Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| gynecologic surgery - robot assisted coelioscopy | Procedure | — | UNRESOLVED |
| gynecologic surgery - standard coelioscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Standard Coelioscopy
- description
- gynecologic surgery - standard coelioscopy
- interventionNames
- Procedure: gynecologic surgery - standard coelioscopy
- type
- EXPERIMENTAL
- label
- Robot-assisted coelioscopy
- description
- gynecologic surgery - robot assisted coelioscopy
- interventionNames
- Procedure: gynecologic surgery - robot assisted coelioscopy
Primary outcomes (1)
- measure
- Perioperative morbidity at six months
- timeFrame
- six months after surgery
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDNarducci F, Bogart E, Hebert T, Gauthier T, Collinet P, Classe JM, Lecuru F, Delest A, Motton S, Conri V, Ferrer C, Marchal F, Ferron G, Probst A, Thery J, Le Deley MC, Lefebvre D, Francon D, Leblanc E, Lambaudie E. Severe perioperative morbidity after robot-assisted versus conventional laparoscopy in gynecologic oncology: Results of the randomized ROBOGYN-1004 trial. Gynecol Oncol. 2020 Aug;158(2):382-389. doi: 10.1016/j.ygyno.2020.05.010. Epub 2020 May 25. PMID 32467054