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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-01

Study Completion Date

2018-03-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Optimising Microsurgical Reconstruction After Advanced Head and Neck Cancers

NCT04308525

Head and Neck Cancer

UNKNOWN

The Effect of ERAS on Pancreaticoduodenectomy (v2.0)

NCT06009224

Periampullary Cancer Borderline Malignancy Tumor

NOT_YET_RECRUITING NA

ERAS Program Improves Recovery of HCC Patient Undergoing Hepatectomy

NCT03104920

HCC

UNKNOWN NA

ERAS® Guidelines Validation of CRS With or Without HIPEC

NCT05185791

Peritoneal Diseases

UNKNOWN

Contribution of Oncovascular Surgery in the Treatment of Gynecological Advanced Malignant Diseases.

NCT07267780

Ovarian Carcinoma Cervical Carcinoma Endometrial Carcinoma +3 more

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

FAST-TRACK Group

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.

Group Type EXPERIMENTAL

Fast-Track Protocol

Intervention Type PROCEDURE

Classical management group

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.

Group Type ACTIVE_COMPARATOR

Usual management

Intervention Type PROCEDURE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fast-Track Protocol

Intervention Type PROCEDURE

Usual management

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Enhanced Recovery After Surgery ERAS protocol Classical management Conventional care

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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).

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No