Clinical trial · Interventional
Diaphragmatic Resection And Gynecological Ovarian Neoplasm
NCT03543462CI-TRIAL-00045224DRAGONcompletedPhase 4ClinicalTrials.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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| thoracic Drain Tube 24 Fr. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Arm A: Chest tube positioning YES
- description
- Patients enrolled for chest tube positioning
- interventionNames
- Device: thoracic Drain Tube 24 Fr.
- type
- NO_INTERVENTION
- label
- Arm B: Chest tube positioning NO
- description
- Patients enrolled for diaphragm closure without chest tube positioning
Primary outcomes (1)
- measure
- Measurement of incidence of pleural effusion after diaphragmatic resection and useful of chest drain to prevent pleural effusion and consequent respiratory symptoms as dyspnea.
- timeFrame
- 30 days
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (13)
- BACKGROUNDSiegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17. PMID 23335087
- BACKGROUNDEisenkop SM, Spirtos NM. What are the current surgical objectives, strategies, and technical capabilities of gynecologic oncologists treating advanced epithelial ovarian cancer? Gynecol Oncol. 2001 Sep;82(3):489-97. doi: 10.1006/gyno.2001.6312. PMID 11520145
- BACKGROUNDBristow RE, Tomacruz RS, Armstrong DK, Trimble EL, Montz FJ. Survival effect of maximal cytoreductive surgery for advanced ovarian carcinoma during the platinum era: a meta-analysis. J Clin Oncol. 2002 Mar 1;20(5):1248-59. doi: 10.1200/JCO.2002.20.5.1248. PMID 11870167
- BACKGROUNDWinter WE 3rd, Maxwell GL, Tian C, Carlson JW, Ozols RF, Rose PG, Markman M, Armstrong DK, Muggia F, McGuire WP; Gynecologic Oncology Group Study. Prognostic factors for stage III epithelial ovarian cancer: a Gynecologic Oncology Group Study. J Clin Oncol. 2007 Aug 20;25(24):3621-7. doi: 10.1200/JCO.2006.10.2517. PMID 17704411
- BACKGROUNDAletti GD, Dowdy SC, Podratz KC, Cliby WA. Surgical treatment of diaphragm disease correlates with improved survival in optimally debulked advanced stage ovarian cancer. Gynecol Oncol. 2006 Feb;100(2):283-7. doi: 10.1016/j.ygyno.2005.08.027. Epub 2005 Sep 22. PMID 16182350
- BACKGROUNDTsolakidis D, Amant F, Van Gorp T, Leunen K, Neven P, Vergote I. The role of diaphragmatic surgery during interval debulking after neoadjuvant chemotherapy: an analysis of 74 patients with advanced epithelial ovarian cancer. Int J Gynecol Cancer. 2010 May;20(4):542-51. doi: 10.1111/IGC.0b013e3181d4de23. PMID 20686373
- BACKGROUNDZapardiel I, Peiretti M, Zanagnolo V, Biffi R, Bocciolone L, Landoni F, Aletti G, Colombo N, Maggioni A. Diaphragmatic surgery during primary cytoreduction for advanced ovarian cancer: peritoneal stripping versus diaphragmatic resection. Int J Gynecol Cancer. 2011 Dec;21(9):1698-703. doi: 10.1097/IGC.0b013e31822f65c3.