Diaphragmatic Resection And Gynecological Ovarian Neoplasm
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Enrollment
- 88
- Locations
- 2
- Primary Endpoint
- Measurement of incidence of pleural effusion after diaphragmatic resection and useful of chest drain to prevent pleural effusion and consequent respiratory symptoms as dyspnea.
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Investigator)
Masking Description
The investigator check the random list only when the patients is enrolled.
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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)
Secondary Outcomes
No secondary outcomes reported
Investigators
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