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Minimally Invasive Interval Debulking Surgery in Ovarian Neoplasm: a Feasibility Study

NCT02324595 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-04-13

No results posted yet for this study

Summary

Phase II multicentric study

Conditions

  • Stage IV Ovarian Carcinoma
  • Effects of Chemotherapy
  • Peritoneal Cavity Cancer

Interventions

PROCEDURE

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

Sponsors & Collaborators

  • Fagotti, Anna, M.D.

    collaborator INDIV

  • Fanfani, Francesco, M.D.

    collaborator INDIV

  • Salvatore Gueli Alletti

    collaborator UNKNOWN

  • Catholic University of the Sacred Heart

    lead OTHER

Principal Investigators

  • Giovanni Scambia, Prof · Catholic University of the Sacred Heart

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2015-02-28
Completion
2016-02-29

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02324595 on ClinicalTrials.gov