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Diaphragmatic Resection And Gynecological Ovarian Neoplasm (DRAGON)

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ClinicalTrials.gov Identifier: NCT03543462
Recruitment Status : Recruiting
First Posted : June 1, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Prof. Giovanni Scambia, Catholic University of the Sacred Heart

Brief Summary:

Prospective randomized phase IV study aimed to value the impact of diaphragmatic surgery and the useful of intra-operatory thoracic drain in advanced ovarian cancer.

Considering the fact that the diaphragmatic surgery could contribute with the incidence of post-operatory morbidity. The study is aimed to value the role of thoracic drain in post-operative outcomes as hospital stay, time to chemotherapy, drugs use and eventual interventions.


Condition or disease Intervention/treatment Phase
Ovarian Cancer Device: thoracic Drain Tube 24 Fr. Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Patients affected by advanced stage ovarian cancer with diaphragmatic involvement. When diaphragmatic resection is performed the patients are randomized to proceed with chest drain positioning or not
Masking: Single (Investigator)
Masking Description: The investigator check the random list only when the patients is enrolled.
Primary Purpose: Treatment
Official Title: Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Actual Study Start Date : March 20, 2018
Estimated Primary Completion Date : March 1, 2019
Estimated Study Completion Date : April 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ovarian Cancer

Arm Intervention/treatment
Sham Comparator: Arm A: Chest tube positioning YES
Patients enrolled for chest tube positioning
Device: thoracic Drain Tube 24 Fr.
Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair

No Intervention: Arm B: Chest tube positioning NO
Patients enrolled for diaphragm closure without chest tube positioning



Primary Outcome Measures :
  1. Measurement of incidence of pleural effusion after diaphragmatic resection and useful of chest drain to prevent pleural effusion and consequent respiratory symptoms as dyspnea. [ Time Frame: 30 days ]

    The diaphragmatic surgery is often related to post-operative complication. The most common complication is pleural effusion. This condition contribute to decrease the clinical outcomes causing increase of hospitalization and necessity medical or surgical treatment.

    The main outcome is to asses a correct management of intra-operatory thoracic drain position after diaphragmatic surgery.

    The outcomes measured are:

    - Incidence of post-operatory pleural effusion detected by chest RX measuring pleural fluid collection (cm)



Other Outcome Measures:
  1. Time to start chemotherapy [ Time Frame: 40 Days ]

    The time to start chemotherapy is fundamental from oncological point of view. The ideal time to start chemotherapy treatment should exceed 40 days after surgery.

    The data measured are

    - time between surgery and first chemotherapy cycle


  2. Estimated blood loss [ Time Frame: 1 Day ]

    The intra operative blood loss is often related to the complexity of procedure and consequently to post-operative complications

    The data measured are:

    - EBL (ml)


  3. Operative time [ Time Frame: 1 Day ]

    The Operative time is often related to the complexity of procedure and consequently to post-operative complications

    The data measured are:

    - Operative time (minutes)




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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 < 80 years
  • Patient's informed consent
  • American Society of Anesthesiologists: < class III or IV
  • No actual pregnancies or pelvic inflammatory disease (P.I.D.)
  • BMI < 40
  • Macroscopic diaphragmatic disease infiltration (mono lateral)
  • Grade IIIA-IV diaphragmatic resection score
  • Advanced stage ovarian cancer (stage III-IV)
  • Primary diagnosis, interval debulking surgery, recurrent disease
  • All histotype included

Exclusion Criteria:

  • Actual pregnancies or P.I.D
  • BMI > 40
  • Pulmonary or thoracic preoperatory disease
  • Preoperative pleural effusion
  • Residual thoracic disease after surgery
  • Residual diaphragmatic disease after surgery

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03543462


Contacts
Contact: Stefano Cianci, M.D. 00393336598361 stefano.cianci@policlinicogemelli.it
Contact: Stefano Cianci, M.D. 3336598361 stefano.cianci@policlinicogemelli.it

Locations
Italy
Fondazione Policlinico Agostino Gemelli Recruiting
Roma, Rome, Italy, 00191
Contact: Stefano Cianci    3336598361    stefano.cianci@policlinicogemelli.it   
Principal Investigator: Stefano Cianci, M.D.         
Sub-Investigator: Anna Fagotti, M.D.         
Sub-Investigator: Salvatore Gueli Alletti, M.D.         
Sub-Investigator: Giuseppe Vizzielli, M.D.         
Sub-Investigator: Camilla Fedele, M.D.         
Sub-Investigator: Barbara Costantini, M.D.         
Sub-Investigator: Valerio Gallotta, M.D.         
Sub-Investigator: Stefano Uccella, M.D.         
Sub-Investigator: Giovanni Scambia, M.D.         
Sponsors and Collaborators
Catholic University of the Sacred Heart
Investigators
Principal Investigator: Stefano Cianci, M.D. Fondazione Policlinico Agostino Gemelli

Publications:

Responsible Party: Prof. Giovanni Scambia, Head of Department of Women's and Children's Health, Policlinico Agostino Gemelli Foundation University Hospital, Rome, Italy, Catholic University of the Sacred Heart
ClinicalTrials.gov Identifier: NCT03543462     History of Changes
Other Study ID Numbers: D.R.A.G.O.N. ID. 1963
First Posted: June 1, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Prof. Giovanni Scambia, Catholic University of the Sacred Heart:
Ovarian Cancer
Diaphragm
Chest Drain
Diaphragmatic Resection
Pleural Effusion

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders