Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Condition: Ovarian Cancer
MeSH terms: Neoplasms; Ovarian Neoplasms
Study type: Interventional
Phase: Phase 4

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.
    

Detailed description: 
      Ovarian cancer represents the leading cause of death from gynecologic malignancies. The
      majority of patients present with advanced-stage disease (III/IV) often involving the upper
      abdomen. Spread by either direct extension or via peritoneal implantation can result in
      metastases to the diaphragm, as seen in up to 40% of patients with advanced disease.

      Standard treatment of advanced-stage disease includes primary cytoreductive surgery followed
      by combination platinum-taxane chemotherapy. Optimal cytoreduction to ≤1 cm disease has
      repeatedly been shown to be associated with improved survival.

      Diaphragm involvement was considered one of the most frequent obstacles to achieving optimal
      cytoreduction. The right diaphragm is more frequently and extensively involved than the left
      diaphragm; however, bilateral involvement is not uncommon. Various studies have advocated and
      reported the feasibility of diaphragmatic surgery in achieving optimal cytoreduction.

      Sometimes, depending on extent of the disease, the diaphragm involvement could be massive and
      often the resection of the muscle with access to pleural cavity is necessary. Allegedly,
      entering the pleural cavity increases the morbidity of the procedure.

      Extensive upper abdominal surgery involving diaphragmatic peritonectomy/resection and liver
      mobilization may both contribute to the development of symptomatic pleural effusions.

      The aim of the study is to value the impact of diaphragmatic surgery in post-operative
      complications using a specific score (DRS). The other aim is to asses a correct management of
      intra-operatory thoracic drain position after diaphragmatic surgery. All parameter that could
      influence the post-operative outcomes as (EBL,BMI, OT, SCS) are recorded.

      The study was approved by Ethical Committee of Fondazione Policlinico Gemelli Hospital (prot
      n. 9078/18).

      The study is a superiority randomized clinical trial to investigate the role of
      intra-operative chest tube in the large (> 5 cm) diaphragmatic peritonectomy/resection in the
      ovarian cancer debulking. Calculation of sample size for the analysis of the primary
      end-point (major pleural effusion) was based on literature results reporting a rate of
      moderate/severe early peri-operative pleural effusion between 54% and 23% when a large (> 5
      cm) diaphragmatic resection is performed. A sample size of 88 patients was required in order
      to provide 80% power of detecting a reduction of 60% of moderate/severe pleural effusion in
      PDS with large diaphragmatic resection when intra-operative chest tube was inserted (overall
      rate 22%) (two-tailed α =0.05, drop-out 5%).

      Sample size is composed by 44 Patients affected by advanced stage ovarian cancer, meeting
      inclusion criteria, undergo diaphragmatic surgery followed by intra-operatory thoracic drain
      position and 44 patients with same characteristics undergo to diaphragmatic surgery without
      intra-operatory thoracic drain position. Both groups are compared in terms of incidence of
      post-operative complications (especially pleural effusion, pneumothorax, respiratory
      disease). Secondary endpoints are the evaluation of surgical outcomes and clinical outcomes
      in terms hospital stay, procedures and radiologic examinations required. All patients are
      adequately informed and inserted in the study only after having read and signed an informed
      consent. Diagnostic, clinical and surgical data of each patient are prospectively recorded.

      Surgical procedures consist of surgical standard cytoreduction, performed for all cases of
      advanced stage ovarian cancer disease. The procedures performed depending on disease spread.

      The diaphragmatic procedures, depending on the disease infiltration can consists of
      superficial peritonectomy, deep peritonectomy (until muscular layer) or diaphragmatic
      resection. Considering the randomization, if required, a thoracic drain tube 24 Fr. is
      positioned. A post-operative chest X-Ray is performed on all cases.

      At the end of the procedure, a schedule is compiled with intraoperative data.

      Post-operative examinations are follows:

        -  Chest X-Ray (2 h post-op)

        -  Chest X-Ray (day 1)

        -  Chest X-Ray (if required, depending of clinical indications)

        -  Thoracic US scan evaluation before discharge

        -  Thoracic US scan evaluation 10 days after discharge

        -  Radiological examinations (if required, depending of clinical indications)

      All clinical and histologic data will be recorded prospectively using an electronic database.
    

Intervention name(s): thoracic Drain Tube 24 Fr.
Intervention type(s): Device
Intervention description(s): Positioning of Thoracic Drain after diaphragmatic resection and consequently diaphragmatic repair
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)
Primary purpose: Treatment
Keywords: Ovarian Cancer; Diaphragm; Chest Drain; Diaphragmatic Resection; Pleural Effusion