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

Not Applicable

Completed

• Conditions: Surgery Related Complications Rate; Readmission Rate; Cost Per Patient Rate; Median Length of Stay
• Interventions: Procedure: Fast-Track Protocol; Procedure: Usual management

• Registration Number: NCT02172638
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Study First Submitted: 2014-06-13
• Study First Submitted QC: 2014-06-20
• Study First Posted: 2014-06-24
• Primary Completion: 2018-03-30
• Study Completion: 2018-03-30
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FAST-TRACK Group	Fast-Track Protocol	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.
Classical management group	Usual management	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.

Primary Outcome Measures

Name	Time	Method
median length of stay	participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcome Measures

Name	Time	Method
Number of surgery related complications	28 days after surgery.	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.
Cost per patient	28 days after surgery	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.
Number of readmissions related to postoperative complications.	28 days after surgery	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.

Trial Locations

Locations (1)

Hospital Universitari Vall d'Hebron; 🇪🇸 Barcelona, Spain