Diaphragmatic Resection And Gynecological Ovarian Neoplasm

NCT03543462 | Completed Phase 4 DMC

• 1 other identifier: D.R.A.G.O.N. ID. 1963
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Cancer

Keywords

Ovarian Cancer; Diaphragm; Chest Drain; Diaphragmatic Resection; Pleural Effusion

Outcome Measures

Primary Outcomes (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.

  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)

  30 days

Other Outcomes (3)

• Time to start chemotherapy

  40 Days

• Estimated blood loss

  1 Day

• Operative time

  1 Day

Study Arms (2)

Arm A: Chest tube positioning YES

SHAM COMPARATOR

Patients enrolled for chest tube positioning

Device: thoracic Drain Tube 24 Fr.

Arm B: Chest tube positioning NO

NO INTERVENTION

Patients enrolled for diaphragm closure without chest tube positioning

Interventions

thoracic Drain Tube 24 Fr. DEVICE

Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair

Arm A: Chest tube positioning YES

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Fondazione Policlinico Agostino Gemelli

Roma, Rome, 00191, Italy

Location

Related Publications (13)

• Siegel 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 BACKGROUND

• Eisenkop 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 BACKGROUND

• Bristow 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 BACKGROUND

• Winter 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 BACKGROUND

• Aletti 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 BACKGROUND

• Tsolakidis 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 BACKGROUND

• Zapardiel 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.

  PMID: 22080893 BACKGROUND

• Fanfani F, Fagotti A, Gallotta V, Ercoli A, Pacelli F, Costantini B, Vizzielli G, Margariti PA, Garganese G, Scambia G. Upper abdominal surgery in advanced and recurrent ovarian cancer: role of diaphragmatic surgery. Gynecol Oncol. 2010 Mar;116(3):497-501. doi: 10.1016/j.ygyno.2009.11.023. Epub 2009 Dec 11.

  PMID: 20004958 BACKGROUND

• Chereau E, Ballester M, Selle F, Cortez A, Pomel C, Darai E, Rouzier R. Pulmonary morbidity of diaphragmatic surgery for stage III/IV ovarian cancer. BJOG. 2009 Jul;116(8):1062-8. doi: 10.1111/j.1471-0528.2009.02214.x. Epub 2009 May 14.

  PMID: 19459863 BACKGROUND

• Devolder K, Amant F, Neven P, van Gorp T, Leunen K, Vergote I. Role of diaphragmatic surgery in 69 patients with ovarian carcinoma. Int J Gynecol Cancer. 2008 Mar-Apr;18(2):363-8. doi: 10.1111/j.1525-1438.2007.01006.x.

  PMID: 18334014 BACKGROUND

• Eisenhauer EL, D'Angelica MI, Abu-Rustum NR, Sonoda Y, Jarnagin WR, Barakat RR, Chi DS. Incidence and management of pleural effusions after diaphragm peritonectomy or resection for advanced mullerian cancer. Gynecol Oncol. 2006 Dec;103(3):871-7. doi: 10.1016/j.ygyno.2006.05.023. Epub 2006 Jul 3.

  PMID: 16815536 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

• Cliby W, Dowdy S, Feitoza SS, Gostout BS, Podratz KC. Diaphragm resection for ovarian cancer: technique and short-term complications. Gynecol Oncol. 2004 Sep;94(3):655-60. doi: 10.1016/j.ygyno.2004.04.032.

  PMID: 15350355 BACKGROUND

MeSH Terms

Conditions

Ovarian Neoplasms; Pleural Effusion

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders; Pleural Diseases; Respiratory Tract Diseases

Study Officials

• Stefano Cianci, M.D.

  Fondazione Policlinico Agostino Gemelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: The investigator check the random list only when the patients is enrolled.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Women's and Children's Health, Policlinico Agostino Gemelli Foundation University Hospital, Rome, Italy

Model Details: 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

Study Record Dates

• First Submitted: March 21, 2018
• First Posted: June 1, 2018
• Study Start: March 20, 2018
• Primary Completion: November 11, 2019
• Study Completion: January 11, 2020
• Last Updated: May 22, 2020

Record last verified: 2020-05

Locations

IT (1)