Median Length of StayPROFASTNCT02172638
Postoperatory Recovery in Advanced Ovarian Cancer, Fast-Track Protocol vs. Classical Management
A study testing Fast-Track Protocol and Usual management in people with Median Length of Stay and Readmission Rate, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Median Length of Stay, Readmission Rate, Surgery Related Complications Rate
- What is being tested?
- Fast-Track Protocol and Usual management
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2014to 30 Mar 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado
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
- Being tested
- Fast-Track Protocol, Usual management
- Keywords
- Enhanced Recovery After Surgery, ERAS, Fast-Track, Ovarian cancer, Gynecologic surgery, Gynecology oncology, Median length of stay, Readmission rate, Surgery related complications, Cost
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fast-Track ProtocolProcedure or surgery
Also called Enhanced Recovery After Surgery, ERAS protocol
Usual managementProcedure or surgery
Also called Classical management, Conventional care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Usual management |
What is being measured
The primary outcome is the main question the study is designed to answer.
median length of stay
Measured: 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.
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.
Measured: 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.
Measured: 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.
Measured: 28 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start1 Jun 2014
- Primary completion30 Mar 2018
- Study completion30 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Median Length of StayStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antonio Gil Moreno, MD, Study director, Hospital Vall d'HebronJosé Luis Sánchez Iglesias, MD, Principal investigator, Hospital Vall d'Hebron
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172638
- Sponsor's protocol ID
- PR(AMI)136/2014
- Acronym
- PROFAST
- Status last verified
- Sep 2019
- First submitted
- 13 Jun 2014
- Last updated
- 30 Sep 2019
- Results posted
- No
Publications
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.
PubMed 9175983Delaney 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.
PubMed 11683754Chau 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.
PubMed 35289396Sanchez-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.
PubMed 32688208
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ensayo clínico Comparando Recuperación Postoperatoria Tras Protocolo FAST- TRACK Vs. Manejo Clásico en Cáncer de Ovario Avanzado
- ClinicalTrials.gov ID
- NCT02172638
- Acronym / sponsor ID
- PROFAST / PR(AMI)136/2014
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 1 Jun 2014 (actual)
- Primary completion
- 30 Mar 2018 (actual)
- Study completion
- 30 Mar 2018 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FAST-TRACK Group | Experimental | Procedure: Fast-Track ProtocolPatients 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 | Active comparator | Procedure: Usual managementPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fast-Track ProtocolAlso: Enhanced Recovery After Surgery, ERAS protocol | Procedure or surgery | FAST-TRACK Group |
| Usual managementAlso: Classical management, Conventional care | Procedure or surgery | Classical management group |
Primary outcome
median length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks.
3 secondary outcomes
Number of readmissions related to postoperative complications.
Time frame: 28 days after surgery
Number of surgery related complications
Time frame: 28 days after surgery.
Cost per patient
Time frame: 28 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2019.
- Background: PubMed 9175983Kehlet 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.
- Background: PubMed 11683754Delaney 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.
- Derived from this study: PubMed 35289396Chau 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.
- Derived from this study: PubMed 32688208Sanchez-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.
- Related InfoLink provided by the sponsor.
Related trials for Median Length of Stay
Not yet recruiting
Impact of Nurses' Behavior Change and Evidence-Based Practice Implementation on Quality Indicators in Intensive Care Units in Low- and Middle-Income Countries
Ventilator-Associated Pneumonia (VAP), Central Line-Associated Bloodstream Infection
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Gil Moreno, MD study director
Hospital Vall d'Hebron
José Luis Sánchez Iglesias, MD principal investigator
Hospital Vall d'Hebron
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fast-Track Protocol and Usual management in people with Median Length of Stay and Readmission Rate, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
median length of stay (time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02172638, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2019.