Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study
NCT ID: NCT02324595
Last Updated: 2016-04-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
30 participants
INTERVENTIONAL
2013-12-31
2016-02-29
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Debulking Surgery in Ovarian Cancer
NCT03378128
Surgical Complications Related to Primary or Interval Debulking in Ovarian Neoplasm
NCT01461850
Minimally Invasive Interval Debulking Surgery in Advanced Ovarian Cancer
NCT07031908
Laparoscopic Staging in Patients With Ovarian, Fallopian Tube, or Other Primary Abdominal Cancers
NCT00002538
Neoadjuvant Chemotherapy in Epithelial Ovarian Cancer
NCT02125513
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Laparoscopic Interval Debulking Surgery
Patients affected by advanced epithelial ovarian cancer already submitted to neoadjuvant chemotherapy with evidence of complete/partial response
Laparoscopic interval debulking surgery
Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Laparoscopic interval debulking surgery
Diagnostic laparoscopy with a careful exploration of peritoneal cavity: if available a 5 mm "flexible tip" videolaparoscope will be used to explore all peritoneal recesses.For eligible patients,will be placed 3 5mm trocar in standard position for pelvic surgery:cytoreduction will consist in total/radical hysterectomy,bilateral salpingo-oophorectomy,radical omentectomy.If needed pelvic/upper peritonectomy will be performed:in these cases additional trocar can be placed in right or left subcostal spaces. All surgical procedure requested will have be carried out by laparoscopy/robotic or by laparotomy,in case of increased surgical risk or technical impossibility:the case will be registered as laparotomic conversion.At the end of surgical procedures residual tumor will be registered
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Advanced ovarian cancer submitted to neoadjuvant chemotherapy,
* Clinical or serological complete/partial response (RECIST; GCIG),
* PS ≤ 2 (ECOG),
* Informed consent
Exclusion Criteria
* Stable/progressive disease,
* ASA 3-4,
* Severe cardiopulmonary disease,
* BMI \> 40
18 Years
90 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Fagotti, Anna, M.D.
INDIV
Fanfani, Francesco, M.D.
INDIV
Salvatore Gueli Alletti
UNKNOWN
Catholic University of the Sacred Heart
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof. Giovanni Scambia
Director, Dip per la Tutela della Salute della Donna e della Vita Nascente, del Bambino e dell'Adolescente
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giovanni Scambia, Prof
Role: PRINCIPAL_INVESTIGATOR
Catholic University of the Sacred Heart
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Catholic University of Sacred Heart Rome,
Rome, Rome, Italy
Policlinico Agostino Gemelli
Rome, Rome, Italy
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Gueli Alletti S, Bottoni C, Fanfani F, Gallotta V, Chiantera V, Costantini B, Cosentino F, Ercoli A, Scambia G, Fagotti A. Minimally invasive interval debulking surgery in ovarian neoplasm (MISSION trial-NCT02324595): a feasibility study. Am J Obstet Gynecol. 2016 Apr;214(4):503.e1-503.e6. doi: 10.1016/j.ajog.2015.10.922. Epub 2015 Oct 31.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
10279/14
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.