Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Analgesics

Anesthetics

Analgesics, Opioid

Analgesics, Non-Narcotic

Patients in this group will be managed according to an specifically designed FAST-TRACK protocol which will include: Preoperatory nutritional management and coaching by surgeon, anesthetist, nutritionist and specifically trained nurse personnel, reduced preoperatory fasting, avoiding use of intraabdominal drainages, specific anesthetic management to reduce intraoperative stress, avoiding use of Nasogastric tube, avoiding the need for major opioid in postoperatory analgesia and use of an standardized postoperatory management protocol directed to obtain an early oral intake and mobilization with a the goal of normal diet and deambulation in the 3rd day after surgery.

Patients assigned to this group will receive the standard management preformed in our center until now. This management includes a preoperatory control exclusively by the surgeon and anesthetist, minimum of 8h fasting previous to surgery, loose use of intraabdominal drainage , systematic use of nasogastric tube whenever rectum resection or omentectomy is performed, Postoperative analgesia following standing Vall d'Hebron protocols for Moderate-severe postoperative pain, which include use of combined analgesia with non opioids drugs and major Opioids, and usual flexible, non standardized postoperatory management with mobilization and oral intake progression depending on perceived evolution by attending surgeon.

Fast-Track Protocol

Usual management

Antonio Gil Moreno, MD

José Luis Sánchez Iglesias, MD

The concept of Fast-trak or Enhanced Recovery After Surgery ( ERAS) represents a new approach to the management of patients undergoing major surgery that re-examine traditional practices, replacing them if necessary with the best evidence based practices, creating a multimodal perioperative care pathway designed to achieve early recovery. In Colorectal Cancer Surgery , as well as in a number of other procedures it has been shown to reduce Hospitalization by more than 30% without increasing the rate complications or readmissions.

However information on the results of Fast-track protocols when applied to Gynecological patients is sparse, being especially notorious the lack of data regarding the efficacy of Fast-track in the management of Advanced Gynecological cancer.

Hypothesis: the application of a Fast-Track protocol in the management of patients with advanced Ovarian Cancer( Stage III, IV and relapses) may improve the postoperatory recovery of these patients allowing for an early discharge and significant cost reduction, when compared with de usual management, without increasing the number readmission or surgery related complications.

Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management

Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado

To determine if there is an statistically significant difference in the readmission rate related to postoperative complications between the Fast-track and Classical management groups.

To determine if there is an statistically significant difference in surgery related complications rates between the Fast-track and Classical management groups.

The number and severity will be recorded. as graded in the Clavien-Dindo Classification of Surgical Complications.

To determine if the application of a Fast-Track protocol in advanced ovarian cancer patients generates a significant cost per patient reduction when compared with classical management. The total cost for Hospitalization , readmissions and surgery related complications will be assessed according to the Public prices published in : SLT/383/2009, 21th January "Diari Oficial de la Generalitat de Catalunya" Núm. 5325 - 24.2.2009.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management	NCT02172638	Median Length o... Readmission Rat... Surgery Related... Cost Per Patien...	Fast-Track Prot... Usual managemen...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management	NCT02172638	Median Length o... Readmission Rat... Surgery Related... Cost Per Patien...	Fast-Track Prot... Usual managemen...	18 Years -	Hospital Universitari Vall d'Hebron Research Institute

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