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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgery Related Complications Rate, Median Length of Stay, Readmission Rate, Cost Per Patient Rate

Intervention / Treatment
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* Procedure: Fast-Track Protocol
* Procedure: Usual management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or more Advanced ovarian cancer ( FIGO Stages III-IV, and relapses) tributary to laparotomic surgical management. Patient accepts participation in the study and signs informed consent. Exclusion Criteria: ASA IV Active ischemic cardiac condition Advanced cirrhosis ( Child-Pugh B -C). Severe Psychiatric condition ( patient not capable of giving her informed consent properly, not capable or not willing to attend Follow-up visits).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FAST-TRACK Group<br>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. | Procedure: Fast-Track Protocol<br> <br> * Other names: ERAS protocol;|
| Active Comparator: Classical management group<br>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. | Procedure: Usual management<br> <br> * Other names: Conventional care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| median length of stay |  | participants will be followed for the duration of hospital stay, an expected average of 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of readmissions related to postoperative complications. | 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. | 28 days after surgery | 
| Number of surgery related complications | 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. | 28 days after surgery. | 
| Cost per patient | 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. | 28 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cost, Enhanced Recovery After Surgery, ERAS, Fast-Track, Ovarian cancer, Gynecologic surgery, Gynecology oncology, Median length of stay, Readmission rate, Surgery related complications