Diaphragmatic Resection And Gynecological Ovarian Neoplasm (DRAGON)
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|ClinicalTrials.gov Identifier: NCT03543462|
Recruitment Status : Completed
First Posted : June 1, 2018
Last Update Posted : May 22, 2020
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||88 participants|
|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 Description:||The investigator check the random list only when the patients is enrolled.|
|Official Title:||Diaphragmatic Resection And Gynecological Ovarian Neoplasm|
|Actual Study Start Date :||March 20, 2018|
|Actual Primary Completion Date :||November 11, 2019|
|Actual Study Completion Date :||January 11, 2020|
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
- 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)
- 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
- 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)
- 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)
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
|Fondazione Policlinico Agostino Gemelli|
|Roma, Rome, Italy, 00191|
|Principal Investigator:||Stefano Cianci, M.D.||Fondazione Policlinico Agostino Gemelli|