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

NCT02172638 | Completed

• 1 other identifier: PR(AMI)136/2014
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Enhanced Recovery After Surgery; ERAS; Fast-Track; Ovarian cancer; Gynecologic surgery; Gynecology oncology; Median length of stay; Readmission rate; Surgery related complications; Cost

Outcome Measures

Primary Outcomes (1)

• median length of stay

  participants will be followed for the duration of hospital stay, an expected average of 2 weeks.

Secondary Outcomes (3)

• Number of readmissions related to postoperative complications.

  28 days after surgery

• Number of surgery related complications

  28 days after surgery.

• Cost per patient

  28 days after surgery

Study Arms (2)

FAST-TRACK Group

EXPERIMENTAL

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

Classical management group

ACTIVE COMPARATOR

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

Interventions

Fast-Track Protocol PROCEDURE

Also known as: Enhanced Recovery After Surgery, ERAS protocol

FAST-TRACK Group

Usual management PROCEDURE

Also known as: Classical management, Conventional care

Classical management group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Related Publications (4)

• Kehlet H. Multimodal approach to control postoperative pathophysiology and rehabilitation. Br J Anaesth. 1997 May;78(5):606-17. doi: 10.1093/bja/78.5.606.

  PMID: 9175983 BACKGROUND

• Delaney CP, Fazio VW, Senagore AJ, Robinson B, Halverson AL, Remzi FH. 'Fast track' postoperative management protocol for patients with high co-morbidity undergoing complex abdominal and pelvic colorectal surgery. Br J Surg. 2001 Nov;88(11):1533-8. doi: 10.1046/j.0007-1323.2001.01905.x.

  PMID: 11683754 BACKGROUND

• Chau JPC, Liu X, Lo SHS, Chien WT, Hui SK, Choi KC, Zhao J. Perioperative enhanced recovery programmes for women with gynaecological cancers. Cochrane Database Syst Rev. 2022 Mar 15;3(3):CD008239. doi: 10.1002/14651858.CD008239.pub5.

  PMID: 35289396 DERIVED

• Sanchez-Iglesias JL, Carbonell-Socias M, Perez-Benavente MA, Monreal Clua S, Manrique-Munoz S, Garcia Gorriz M, Burgos-Pelaez R, Segurola Gurrutxaga H, Pamies Serrano M, Pilar Gutierrez-Barcelo MD, Serrano-Castro S, Balcells-Farre MT, Perez-Barragan C, Scaillet-Houberechts A, Cossio-Gil Y, Gil-Moreno A. PROFAST: A randomised trial implementing enhanced recovery after surgery for highcomplexity advanced ovarian cancer surgery. Eur J Cancer. 2020 Sep;136:149-158. doi: 10.1016/j.ejca.2020.06.011. Epub 2020 Jul 18.

  PMID: 32688208 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

Enhanced Recovery After Surgery

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Intervention Hierarchy (Ancestors)

Perioperative Care; Surgical Procedures, Operative

Study Officials

• Antonio Gil Moreno, MD

  Hospital Vall d'Hebron

  STUDY DIRECTOR

• José Luis Sánchez Iglesias, MD

  Hospital Vall d'Hebron

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 13, 2014
• First Posted: June 24, 2014
• Study Start: June 1, 2014
• Primary Completion: March 30, 2018
• Study Completion: March 30, 2018
• Last Updated: September 30, 2019

Record last verified: 2019-09

Locations

ES (1)