Major SurgeryIMPRICANCT03803280
Implementation of Enhanced Recovery Protocol in Spain
An observational study of Major Surgery, run by Grupo Español de Rehabilitación Multimodal at 3 sites in Spain.
Trial summary
The main objective is the multicenter and uniform implementation of a agreed upon perioperative evidence based program emanated from the Enhanced Recovery for abdominal surgery pathway (RICA) published by the Spanish National Health Service and the Aragon Institute of Health, in hospitals of the National Health… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Major Surgery
- What is being tested?
- ERAS program
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 3 sitesSpain
- Study dates
- 15 Jul 2016to 31 Dec 2022
- Phase
- Observational
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes (It is defined as complex major surgery that lasts more than two hours or it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).
Who may be able to join
- Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.
Who cannot join
- Urgent Surgery.
- Patients ASA (American Society of Anesthesiology) IV or higher.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Infanta Leonor
Madrid
Javier Ripollés Melchor, MD, 649337762, ripo542@gmail.com
Eugenio Martínez Hurtado, MD
- Recruiting
Complejo Hospitalario de Salamanca
Salamanca
José Maria Calvo Vecino, Prof, joscalvo@gmail.com
Domingo Bustos García
- Recruiting
Hospital Clínico Universitario Lozano Blesa
Zaragoza
José Manuel Ramírez Rodriguez, Prof, jramirez@unizar.es
Rubén Casans Francés, Phd
About this study
Official title: Implementation of the Enhanced Recovery in Abdominal Surgery Pathway in the National Health Network (IMPRICA Project)
The main objective is the multicenter and uniform implementation of a agreed upon perioperative evidence based program emanated from the Enhanced Recovery for abdominal surgery pathway (RICA) published by the Spanish National Health Service and the Aragon Institute of Health, in hospitals of the National Health Network.
The evaluation and outcomes of such implementation is proposed as a secondary objective. Different established indicator will compared traditional care results with those from the new program in the short and medium term. 10 interested hospital centers are selected. In each of them a retrospective study will be conducted to analyze the clinical results obtained in abdominal surgery in the past six months. After making the necessary training to clinical teams and assure the project development and implementation in each center, a prospective study in which all patients in the program are being recruited will be held. Hospital stay as well as perioperative mortality and morbidity will be collected. We will analyze data from: days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care, time to complete reintegration into family, social and labor environment and quality of life.
Read the detailed description
A uniform, consensual and multicentric implementation of the multidisciplinary Perioperative Medicine Program is proposed, the program comes form the Clinical Pathway of Intensified Recovery in Abdominal Surgery -RICA-, published by the Spanish National Health System as clinical guideline.
It covers the perioperative area in complex abdominal surgery and extends from the moment of diagnosis in the Surgery office until the last revision performed one year after surgery.
It is proposed as a double study; a first retrospective analysis of the results and perioperative complications referred and available in the Centers involved in the study; and a second analysis of results after the implementation of the Program, in the same Centers. Once both are finished, the comparison between them and their communication will be carried out using the appropriate reports.
Actors: Multidisciplinary teams made up of nurses, surgeons, anesthesiologists, nutritionists / endocrinologists, physiotherapists and rehabilitators.
Patients: All patients recruited in the different hospitals for the RICA Perioperative Medicine Program susceptible to performing complex abdominal surgery.
Variables under study: Perioperative complications according to the Clavien-Dindo classification and the European Perioperative Clinical Outcome definitions (EPCO); Times of global hospital stay and in critical care units; the rate of readmissions and the complications derived from them, the rate of surgical reoperations, the analysis of cost per process (including the total cost in the study period-two years-), the time until complete reincorporation into the family environment and socio-labor, the indices of quality perceived by the patient and / or their caregivers, the final quality of life index obtained by each patient (resulting quality of life).
Data collection and analysis: Record of described variables were be included in an "on line"database available to all centers.
Limitations of the Study: impossibility to include all the patients that can be recruited in surgery consultations due to rejection of the staff (negative to the benchmarking and / or to the program) or negative of the patient. Loss of data in follow-up due to the failure of patients. Difficulty in analyzing costs due to lack of economic data in the Centers. Lack of motivation in the multidisciplinary teams. Rupture of the program in case of emergency / emergency.
Material and Methodology:
Participating Centers: Previously selected for their well-known Organizational capacity and their experience and interest.
First Phase: Realization of retrospective study of existing results in each Center in the six months prior to the implementation of the Program and Conformation of the multidisciplinary teams that will implement the Intensified Recovery Program.
Second phase: Training of the Teams in IACS (Instituto Aragones Ciencias de la Salud) on the implementation of enhanced recovery programs provided with online training through platform built "ad hoc" and in person for training with experts. Development of the Normalized Work Protocol (NTP) in each assigned Center and implementation of the forms and database in the Clinical History of the Centers (considering electronic Clinical History).
Third phase: Progressive recruitment of patients and inclusion in the Program (on-line database) and start of the one-year prospective study from the patient's inclusion.
Inclusion Criteria:
-Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes. (It is defined as complex major surgery that lasts more than two hours, it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).
- Conditions
- Major Surgery
- Being tested
- ERAS program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS programProcedure or surgery
ERAS pathway according to the Spanish Via RICA
| Study group | Role | What they receive |
|---|---|---|
| Traditional care | Patients with major abdominal surgery without before a enhanced recovery program was stablished | |
| ERAS care | Patients with major abdominal surgery within a enhanced recovery program was stablished Receives: Procedure: ERAS program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with postoperative complications
complications after surgery
Measured: 30 days after surgery
Mortality
Number of patients dead after surgery
Measured: 3 years
Long term mortality
Number of patients dead after surgery
Measured: 5 years
Secondary outcomes (4)
Hospital stay
Days of stay in hospital after surgery
Measured: perioperative stay
compliance of the protocol
Rate of compliance of each ERAS (Enhanced Recovery After Surgery) item
Measured: 1 month after surgery
re-admission
patient needing hospital stay after being at home after primary surgery
Measured: 1 month after surgery
Cost
Price of the intervention
Measured: 1 month after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start15 Jul 2016
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Major SurgeryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grupo Español de Rehabilitación Multimodal
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria Aragón, Instituto Aragones de Ciencias de la Salud
- Responsible party
- Sponsor
- Investigators
- Jose M Calvo, Dr, Study chair, Grupo Español de Rehabilitación Multimodal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803280
- Sponsor's protocol ID
- GERM03
- Acronym
- IMPRICA
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2019
- Last updated
- 14 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Vorwald P, Bruna Esteban M, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after esophageal resection. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):401-409. doi: 10.1016/j.ciresp.2018.02.010. Epub 2018 Mar 21. English, Spanish.
PubMed 29573788Bruna M, Navarro C, Baez C, Ramirez JM, Ortiz MA. Results of a national survey about perioperative care in gastric resection surgery. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):410-418. doi: 10.1016/j.ciresp.2018.03.004. Epub 2018 Apr 24. English, Spanish.
PubMed 29699695Ruiz-Tovar J, Munoz JL, Royo P, Duran M, Redondo E, Ramirez JM; Grupo Espanol de Rehabilitacion Multimodal (GERM). Implementation of the Spanish ERAS program in bariatric surgery. Minim Invasive Ther Allied Technol. 2018 Dec;27(6):365-372. doi: 10.1080/13645706.2018.1446988. Epub 2018 Mar 8.
PubMed 29519184Bruna Esteban M, Vorwald P, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after surgery in gastric resections. Cir Esp. 2017 Feb;95(2):73-82. doi: 10.1016/j.ciresp.2016.10.013. Epub 2017 Feb 6. English, Spanish.
PubMed 28185641Martinez AB, Longas J, Ramirez JM. A model for lymphocyte activation in open versus laparoscopic surgery in colorectal cancer patients in enhanced recovery after surgery (ERAS) protocols. Int J Colorectal Dis. 2017 Jun;32(6):913-916. doi: 10.1007/s00384-016-2731-2. Epub 2016 Nov 30.
PubMed 27900463Ruiz-Tovar J, Royo P, Munoz JL, Duran M, Redondo E, Ramirez JM; GERM. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):439-443. doi: 10.1097/SLE.0000000000000323.
PubMed 27753710Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
PubMed 27227930Gonzalez-Ayora S, Pastor C, Guadalajara H, Ramirez JM, Royo P, Redondo E, Arroyo A, Moya P, Garcia-Olmo D. Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group on ERAS. Int J Colorectal Dis. 2016 Sep;31(9):1625-31. doi: 10.1007/s00384-016-2621-7. Epub 2016 Jul 4.
PubMed 27378580Esteban F, Cerdan FJ, Garcia-Alonso M, Sanz-Lopez R, Arroyo A, Ramirez JM, Moreno C, Morales R, Navarro A, Fuentes M. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for colorectal cancer surgery. Colorectal Dis. 2014 Feb;16(2):134-40. doi: 10.1111/codi.12472.
PubMed 24164975Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.
PubMed 23052796Arroyo A, Ramirez JM, Callejo D, Vinas X, Maeso S, Cabezali R, Miranda E; Spanish Working Group in Fast Track Surgery (GERM). Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Dis. 2012 Dec;27(12):1637-44. doi: 10.1007/s00384-012-1497-4. Epub 2012 May 27.
PubMed 22645075Ramirez JM, Blasco JA, Roig JV, Maeso-Martinez S, Casal JE, Esteban F, Lic DC; Spanish working group on fast track surgery. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg. 2011 Apr 14;11:9. doi: 10.1186/1471-2482-11-9.
PubMed 21489315
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementation of the Enhanced Recovery in Abdominal Surgery Pathway in the National Health Network (IMPRICA Project)
- ClinicalTrials.gov ID
- NCT03803280
- Acronym / sponsor ID
- IMPRICA / GERM03
- Conditions
- Major Surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Grupo Español de Rehabilitación MultimodalUniversity, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria Aragón, Instituto Aragones de Ciencias de la Salud
- Study start
- 15 Jul 2016 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 14 Jan 2019 (actual)
- 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 main objective is the multicenter and uniform implementation of a agreed upon perioperative evidence based program emanated from the Enhanced Recovery for abdominal surgery pathway (RICA) published by the Spanish National Health Service and the Aragon Institute of Health, in hospitals of the National Health Network.
The evaluation and outcomes of such implementation is proposed as a secondary objective. Different established indicator will compared traditional care results with those from the new program in the short and medium term. 10 interested hospital centers are selected. In each of them a retrospective study will be conducted to analyze the clinical results obtained in abdominal surgery in the past six months. After making the necessary training to clinical teams and assure the project development and implementation in each center, a prospective study in which all patients in the program are being recruited will be held. Hospital stay as well as perioperative mortality and morbidity will be collected. We will analyze data from: days of hospital stay (potential and actual), efficiency (cost/procedure), quality of care, time to complete reintegration into family, social and labor environment and quality of life.
Detailed description
A uniform, consensual and multicentric implementation of the multidisciplinary Perioperative Medicine Program is proposed, the program comes form the Clinical Pathway of Intensified Recovery in Abdominal Surgery -RICA-, published by the Spanish National Health System as clinical guideline.
It covers the perioperative area in complex abdominal surgery and extends from the moment of diagnosis in the Surgery office until the last revision performed one year after surgery.
It is proposed as a double study; a first retrospective analysis of the results and perioperative complications referred and available in the Centers involved in the study; and a second analysis of results after the implementation of the Program, in the same Centers. Once both are finished, the comparison between them and their communication will be carried out using the appropriate reports.
Actors: Multidisciplinary teams made up of nurses, surgeons, anesthesiologists, nutritionists / endocrinologists, physiotherapists and rehabilitators.
Patients: All patients recruited in the different hospitals for the RICA Perioperative Medicine Program susceptible to performing complex abdominal surgery.
Variables under study: Perioperative complications according to the Clavien-Dindo classification and the European Perioperative Clinical Outcome definitions (EPCO); Times of global hospital stay and in critical care units; the rate of readmissions and the complications derived from them, the rate of surgical reoperations, the analysis of cost per process (including the total cost in the study period-two years-), the time until complete reincorporation into the family environment and socio-labor, the indices of quality perceived by the patient and / or their caregivers, the final quality of life index obtained by each patient (resulting quality of life).
Data collection and analysis: Record of described variables were be included in an "on line"database available to all centers.
Limitations of the Study: impossibility to include all the patients that can be recruited in surgery consultations due to rejection of the staff (negative to the benchmarking and / or to the program) or negative of the patient. Loss of data in follow-up due to the failure of patients. Difficulty in analyzing costs due to lack of economic data in the Centers. Lack of motivation in the multidisciplinary teams. Rupture of the program in case of emergency / emergency.
Material and Methodology:
Participating Centers: Previously selected for their well-known Organizational capacity and their experience and interest.
First Phase: Realization of retrospective study of existing results in each Center in the six months prior to the implementation of the Program and Conformation of the multidisciplinary teams that will implement the Intensified Recovery Program.
Second phase: Training of the Teams in IACS (Instituto Aragones Ciencias de la Salud) on the implementation of enhanced recovery programs provided with online training through platform built "ad hoc" and in person for training with experts. Development of the Normalized Work Protocol (NTP) in each assigned Center and implementation of the forms and database in the Clinical History of the Centers (considering electronic Clinical History).
Third phase: Progressive recruitment of patients and inclusion in the Program (on-line database) and start of the one-year prospective study from the patient's inclusion.
Inclusion Criteria:
-Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes. (It is defined as complex major surgery that lasts more than two hours, it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traditional care | – | –Patients with major abdominal surgery without before a enhanced recovery program was stablished |
| ERAS care | – | Procedure: ERAS programPatients with major abdominal surgery within a enhanced recovery program was stablished |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes (It is defined as complex major surgery that lasts more than two hours or it is estimated that it may require the transfusion of at least 2 red cell concentrates or it is estimated a loss greater than or equal to 15% of the patient's blood volumen).
Key inclusion criteria (1 listed)
- Patients over 18 years old, scheduled for major abdominal surgical surgery, due to malignant or benign causes.
Key exclusion criteria (2 listed)
- Urgent Surgery.
- Patients ASA (American Society of Anesthesiology) IV or higher.
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 |
|---|---|---|
| ERAS programERAS pathway according to the Spanish Via RICA | Procedure or surgery | ERAS care |
Primary outcome
Number of patients with postoperative complications
Time frame: 30 days after surgery
complications after surgery
Mortality
Time frame: 3 years
Number of patients dead after surgery
Long term mortality
Time frame: 5 years
Number of patients dead after surgery
4 secondary outcomes
Hospital stay
Time frame: perioperative stay
compliance of the protocol
Time frame: 1 month after surgery
re-admission
Time frame: 1 month after surgery
Cost
Time frame: 1 month after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2022.
- Results publication: PubMed 29573788Vorwald P, Bruna Esteban M, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after esophageal resection. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):401-409. doi: 10.1016/j.ciresp.2018.02.010. Epub 2018 Mar 21. English, Spanish.
- Results publication: PubMed 29699695Bruna M, Navarro C, Baez C, Ramirez JM, Ortiz MA. Results of a national survey about perioperative care in gastric resection surgery. Cir Esp (Engl Ed). 2018 Aug-Sep;96(7):410-418. doi: 10.1016/j.ciresp.2018.03.004. Epub 2018 Apr 24. English, Spanish.
- Results publication: PubMed 29519184Ruiz-Tovar J, Munoz JL, Royo P, Duran M, Redondo E, Ramirez JM; Grupo Espanol de Rehabilitacion Multimodal (GERM). Implementation of the Spanish ERAS program in bariatric surgery. Minim Invasive Ther Allied Technol. 2018 Dec;27(6):365-372. doi: 10.1080/13645706.2018.1446988. Epub 2018 Mar 8.
- Results publication: PubMed 28185641Bruna Esteban M, Vorwald P, Ortega Lucea S, Ramirez Rodriguez JM; Grupo de Trabajo de Cirugia Esofagogastrica del Grupo Espanol de Rehabilitacion Multimodal (GERM). Enhanced recovery after surgery in gastric resections. Cir Esp. 2017 Feb;95(2):73-82. doi: 10.1016/j.ciresp.2016.10.013. Epub 2017 Feb 6. English, Spanish.
- Results publication: PubMed 27900463Martinez AB, Longas J, Ramirez JM. A model for lymphocyte activation in open versus laparoscopic surgery in colorectal cancer patients in enhanced recovery after surgery (ERAS) protocols. Int J Colorectal Dis. 2017 Jun;32(6):913-916. doi: 10.1007/s00384-016-2731-2. Epub 2016 Nov 30.
- Results publication: PubMed 27753710Ruiz-Tovar J, Royo P, Munoz JL, Duran M, Redondo E, Ramirez JM; GERM. Implementation of the Spanish National Enhanced Recovery Program (ERAS) in Bariatric Surgery: A Pilot Study. Surg Laparosc Endosc Percutan Tech. 2016 Dec;26(6):439-443. doi: 10.1097/SLE.0000000000000323.
- Results publication: PubMed 27227930Moya P, Soriano-Irigaray L, Ramirez JM, Garcea A, Blasco O, Blanco FJ, Brugiotti C, Miranda E, Arroyo A. Perioperative Standard Oral Nutrition Supplements Versus Immunonutrition in Patients Undergoing Colorectal Resection in an Enhanced Recovery (ERAS) Protocol: A Multicenter Randomized Clinical Trial (SONVI Study). Medicine (Baltimore). 2016 May;95(21):e3704. doi: 10.1097/MD.0000000000003704.
- Results publication: PubMed 27378580Gonzalez-Ayora S, Pastor C, Guadalajara H, Ramirez JM, Royo P, Redondo E, Arroyo A, Moya P, Garcia-Olmo D. Enhanced recovery care after colorectal surgery in elderly patients. Compliance and outcomes of a multicenter study from the Spanish working group on ERAS. Int J Colorectal Dis. 2016 Sep;31(9):1625-31. doi: 10.1007/s00384-016-2621-7. Epub 2016 Jul 4.
- Results publication: PubMed 24164975Esteban F, Cerdan FJ, Garcia-Alonso M, Sanz-Lopez R, Arroyo A, Ramirez JM, Moreno C, Morales R, Navarro A, Fuentes M. A multicentre comparison of a fast track or conventional postoperative protocol following laparoscopic or open elective surgery for colorectal cancer surgery. Colorectal Dis. 2014 Feb;16(2):134-40. doi: 10.1111/codi.12472.
- Results publication: PubMed 23052796Nygren J, Thacker J, Carli F, Fearon KC, Norderval S, Lobo DN, Ljungqvist O, Soop M, Ramirez J; Enhanced Recovery After Surgery (ERAS) Society, for Perioperative Care; European Society for Clinical Nutrition and Metabolism (ESPEN); International Association for Surgical Metabolism and Nutrition (IASMEN). Guidelines for perioperative care in elective rectal/pelvic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):285-305. doi: 10.1007/s00268-012-1787-6. No abstract available.
- Results publication: PubMed 22645075Arroyo A, Ramirez JM, Callejo D, Vinas X, Maeso S, Cabezali R, Miranda E; Spanish Working Group in Fast Track Surgery (GERM). Influence of size and complexity of the hospitals in an enhanced recovery programme for colorectal resection. Int J Colorectal Dis. 2012 Dec;27(12):1637-44. doi: 10.1007/s00384-012-1497-4. Epub 2012 May 27.
- Results publication: PubMed 21489315Ramirez JM, Blasco JA, Roig JV, Maeso-Martinez S, Casal JE, Esteban F, Lic DC; Spanish working group on fast track surgery. Enhanced recovery in colorectal surgery: a multicentre study. BMC Surg. 2011 Apr 14;11:9. doi: 10.1186/1471-2482-11-9.
- Individual participant dataSharing planned: Undecided
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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.
Jose M Calvo, Dr study chair
Grupo Español de Rehabilitación Multimodal
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Major Surgery, run by Grupo Español de Rehabilitación Multimodal at 3 sites 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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 14 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose M Ramirez, Prof (+34 639776364, jramirez@unizar.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with postoperative complications (time frame: 30 days after surgery). The study lists 3 primary outcomes in all. 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 NCT03803280, which also lists 12 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 14 Jan 2022.