Colon CancerENeRgyNCT03353311
ERAS Lazio Network Clinical Registry
An observational study of Colon Cancer and Diverticulum, Colon, run by PERSIANI ROBERTO at 1 site in Italy.
Trial summary
Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colon Cancer, Diverticulum, Colon
- How many people
- 1,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2014to 1 Nov 2017
- How long will I take part?
- 3 Months
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Open or laparoscopic colorectal surgical resection for a benign/malignant disease independently from patients age or sex
Who may be able to join
- Elective colorectal surgical resection
- Open and Laparoscopic Suregry
- Benign/malignant disease
- independently from age, sex,
Who cannot join
- Emergency colorectal resections
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Unversitario Agostino Gemelli
Roma, Italy, 00168
About this study
Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.
The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.
Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.
Read the detailed description
Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.
Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.
ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.
The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).
Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.
In particular, ERAS for colorectal surgery, includes 24 demonstrated multi-disciplinary.
Aims. the investigators aim to evaluate the adherence to the individual items and the short-term outcomes (postoperative hospitalization, complication rates within 30 days of intervention, re-intervention) in a consecutive series of patients undergoing colorectal resection, in eight centers in the Lazio region, treated according to the ERAS protocol.
Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.
Design. This is a no-profit, spontaneous, observational, non-intervention Audit collecting data in eight surgical Departments based in Lazio region, since September 2014 to October 2017. Each participating center will be depositary of its own data.
Participating Centers.
- UOC General Surgery 1, Fondazione Policlinico Universitario "A. Gemelli ", Rome (Coordinator) -
- Department of Surgery, S. Eugenio Hospital, Rome
- UOD Week-Day Surgery, St. Andrea Hospital, Rome
- UOC General Surgery, Polyclinic University Bio-Medical Campus, Rome
- UO General and Urgent Surgery, Policlinico Casilino Hospital, Rome
- UOC Surgery, San Paolo Hospital, Civitavechia (RM)
- UOC General Surgery, Cristo Re Hospital, Rome
- UOSD Robotic Surgery for General Surgery, San Giovanni-Addolorata Hospital, Rome
Data Collection. Each center will collect the data in a homogeneous Database. The data will be collected in anonymous form and will be aimed at the definition of:
- Duration of postoperative stay
- Short-term morbidity rate (within 30 days) according to Clavien-Dindo classification
- Re-intervention rate (within 30 days)
- Hospital readmission (within 30 days)
- Adherence rate to items of the series All data will be treated sensibly; each patient will be recorded with a sequential center-specific code. For all new patients and for patients seen in follow-up visits, the specific informed consent of the study will be compiled.
Statistical analysis. Categorical variables will be presented as rate and percentages, the continuous variables as mean, median, and standard deviation.
A logistic regression will also be performed, computing items as co-variates, with the end-point of post-operative morbidity and hospital stay.
Sample Size Calculation: 1000 patients, calculated on the basis of the annual case of each participating center.
For the conduct and management of this observational study no additional cost will be charged on NHS funds.
- Conditions
- Colon Cancer, Diverticulum, Colon
- Keywords
- ERAS, Fast-track, colorectal surgery, immuno-nutrition
- Medical subject headings
- Colonic Neoplasms, Diverticulum, Colon
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Enhanced Recovery After Surgery | Patients undergoing elective colorectal surgical resection for benign/malignant disease. A multidisciplinary validated approach based on 24 items including Preadmission information, education and counselling Preoperative optimization (increasing exercise, stop smoking and alcohol consumption should 4 weeks before surgery) No preoperative bowel preparation Use of preoperative carbohydrate drinks Pre-anesthetic medication Prophylaxis against thromboembolism Antimicrobial prophylaxis and skin preparation Standard anesthetic protocol for rapid awakening PONV Mini-invasive surgery No nasogastric dreinage Prevention of intraoperative hypothermia Perioperative fluid management No drains in the peritoneal cavity after colonic anastomosis Early remouval of urinary drainage (24-48 hrs) Prevention of postoperative ileus (including use of postoperative laxatives) Postoperative analgesia Perioperative nutritional care Postoperative control of glucose Early mobilization Auditing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherance to ERAS protocol
Number of items included in the ERAS protocols that were applied in each centre
Measured: 36 months
Secondary outcomes (1)
Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay
Multivariate analysis to relate ERAS items to morbidity or a longer hospital stay (>mean values)
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2017
- Study start1 Sep 2014
- Primary completion1 Oct 2017
- Study completion1 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (49)Papers the sponsor has linked to this study.
- Other trials for Colon CancerStudies 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
- Prospective
- Enrolment
- 1,000 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- PERSIANI ROBERTO
- Sponsor type
- University, hospital or other
- Collaborators
- Azienda Ospedaliera "Sant'Andrea", Policlinico Casilino ASL RMB, San Giovanni Addolorata Hospital, Campus Bio-Medico University, Ospedale San Paolo Civitavecchia, Ospedale Cristo Re - Roma, S.Eugenio Hospital
- Responsible party
- Sponsor-investigator, PERSIANI ROBERTO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03353311
- Sponsor's protocol ID
- FPAG001
- Acronym
- ENeRgy
- Status last verified
- Sep 2025
- First submitted
- 14 Nov 2017
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No individual participant data will be shared
Publications
Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
PubMed 7891489Kehlet 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 9175983Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
PubMed 15896435Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
PubMed 19841366Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
PubMed 28097305Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; 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 colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
PubMed 23052794Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
PubMed 18650627Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
PubMed 16775831Eskicioglu C, Forbes SS, Aarts MA, Okrainec A, McLeod RS. Enhanced recovery after surgery (ERAS) programs for patients having colorectal surgery: a meta-analysis of randomized trials. J Gastrointest Surg. 2009 Dec;13(12):2321-9. doi: 10.1007/s11605-009-0927-2. Epub 2009 May 21.
PubMed 19459015Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
PubMed 12880610Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
PubMed 12765673Awad S, Lobo DN. What's new in perioperative nutritional support? Curr Opin Anaesthesiol. 2011 Jun;24(3):339-48. doi: 10.1097/ACO.0b013e328345865e.
PubMed 21451404Ali Abdelhamid Y, Chapman MJ, Deane AM. Peri-operative nutrition. Anaesthesia. 2016 Jan;71 Suppl 1:9-18. doi: 10.1111/anae.13310.
PubMed 26620142Black PR, Brooks DC, Bessey PQ, Wolfe RR, Wilmore DW. Mechanisms of insulin resistance following injury. Ann Surg. 1982 Oct;196(4):420-35. doi: 10.1097/00000658-198210000-00005.
PubMed 6751244Nygren J, Thorell A, Ljungqvist O. Preoperative oral carbohydrate nutrition: an update. Curr Opin Clin Nutr Metab Care. 2001 Jul;4(4):255-9. doi: 10.1097/00075197-200107000-00002.
PubMed 11458017
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ERAS Lazio Network Clinical Registry
- ClinicalTrials.gov ID
- NCT03353311
- Acronym / sponsor ID
- ENeRgy / FPAG001
- Conditions
- Colon Cancer, Diverticulum, Colon
- Keywords
- ERAS, Fast-track, colorectal surgery, immuno-nutrition
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- PERSIANI ROBERTOUniversity, hospital or other
- Collaborators
- Azienda Ospedaliera "Sant'Andrea", Policlinico Casilino ASL RMB, San Giovanni Addolorata Hospital, Campus Bio-Medico University, Ospedale San Paolo Civitavecchia, Ospedale Cristo Re - Roma, S.Eugenio Hospital
- Study start
- 1 Sep 2014 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Nov 2017 (actual)
- First posted
- 27 Nov 2017 (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.
Enhanced recovery after surgery (ERAS) protocols are programs aiming to implement patients recovery following surgical procedures developed about 25 years ago. ERAS protocols are based on a multi-disciplinary approach encompassing surgery, anesthesiology, nutrition and nursing; each specialty has to fulfill a number of items which have been demonstrated to reduce morbidity rates, hospital stay and to implement functional recovery comparing standard approach. Accordingly, ERAS society developed a Guidelines for a number of procedures, including colorectal.
The aim of this study is to evaluate the adherence over the last years to these protocols in eight Department of Surgery in Rome in a series of colorectal cancer patients.
Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.
Detailed description
Background. The acronym ERAS (Enhanced Recovery After Surgery) refers to a patient-centered, evidence-based multi-disciplinary protocol designed to implement perioperative operation, reduce surgical trauma, and facilitate recovery of physiological functions aiming to an early hospital discharge.
Usually ERAS protocols give a continuum of care starting at home (pre-hospital/pre-admission phase) to continue in followed by the pre-/ intra-/ and post-operative phases.
ERAS includes a wide range of disciplines and specialists, which focus on the needs of the patient in order to improve support by facilitating his return home.
The first author to introduce the fast-track term in rectal surgery was Prof. Henrik Kehlet in the mid-1990s, proposing a multi-modal rehabilitation program aimed to reduce post-surgical stress response, morbidity, mortality and postoperative hospitalization. Since then, a number of studies were conducted leading to the first ERAS protocol; since then, these protocols were reviewed on a regular basis, the last time in 2017 and included in the guidelines by the ERAS society (http://www.erassociety.org).
Currently, it is widely demonstrated that, comparing to a traditional approach, ERAS is associated with a significant reduction in morbidity, days of hospitalization, mortality, implementing early postoperative recovery with a consequent reduction of the costs, without compromising patient safety.
In particular, ERAS for colorectal surgery, includes 24 demonstrated multi-disciplinary.
Aims. the investigators aim to evaluate the adherence to the individual items and the short-term outcomes (postoperative hospitalization, complication rates within 30 days of intervention, re-intervention) in a consecutive series of patients undergoing colorectal resection, in eight centers in the Lazio region, treated according to the ERAS protocol.
Secondary aims are to investigate the correlation of the items adherence with surgical outcome and to establish a network of hospitals aiming to promote ERAS approach on a regional base.
Design. This is a no-profit, spontaneous, observational, non-intervention Audit collecting data in eight surgical Departments based in Lazio region, since September 2014 to October 2017. Each participating center will be depositary of its own data.
Participating Centers.
- UOC General Surgery 1, Fondazione Policlinico Universitario "A. Gemelli ", Rome (Coordinator) -
- Department of Surgery, S. Eugenio Hospital, Rome
- UOD Week-Day Surgery, St. Andrea Hospital, Rome
- UOC General Surgery, Polyclinic University Bio-Medical Campus, Rome
- UO General and Urgent Surgery, Policlinico Casilino Hospital, Rome
- UOC Surgery, San Paolo Hospital, Civitavechia (RM)
- UOC General Surgery, Cristo Re Hospital, Rome
- UOSD Robotic Surgery for General Surgery, San Giovanni-Addolorata Hospital, Rome
Data Collection. Each center will collect the data in a homogeneous Database. The data will be collected in anonymous form and will be aimed at the definition of:
- Duration of postoperative stay
- Short-term morbidity rate (within 30 days) according to Clavien-Dindo classification
- Re-intervention rate (within 30 days)
- Hospital readmission (within 30 days)
- Adherence rate to items of the series All data will be treated sensibly; each patient will be recorded with a sequential center-specific code. For all new patients and for patients seen in follow-up visits, the specific informed consent of the study will be compiled.
Statistical analysis. Categorical variables will be presented as rate and percentages, the continuous variables as mean, median, and standard deviation.
A logistic regression will also be performed, computing items as co-variates, with the end-point of post-operative morbidity and hospital stay.
Sample Size Calculation: 1000 patients, calculated on the basis of the annual case of each participating center.
For the conduct and management of this observational study no additional cost will be charged on NHS funds.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Enhanced Recovery After Surgery | – | –Patients undergoing elective colorectal surgical resection for benign/malignant disease. A multidisciplinary validated approach based on 24 items including Preadmission information, education and counselling Preoperative optimization (increasing exercise, stop smoking and alcohol consumption should 4 weeks before surgery) No preoperative bowel preparation Use of preoperative carbohydrate drinks Pre-anesthetic medication Prophylaxis against thromboembolism Antimicrobial prophylaxis and skin preparation Standard anesthetic protocol for rapid awakening PONV Mini-invasive surgery No nasogastric dreinage Prevention of intraoperative hypothermia Perioperative fluid management No drains in the peritoneal cavity after colonic anastomosis Early remouval of urinary drainage (24-48 hrs) Prevention of postoperative ileus (including use of postoperative laxatives) Postoperative analgesia Perioperative nutritional care Postoperative control of glucose Early mobilization Auditing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Open or laparoscopic colorectal surgical resection for a benign/malignant disease independently from patients age or sex
Key inclusion criteria (4 listed)
- Elective colorectal surgical resection
- Open and Laparoscopic Suregry
- Benign/malignant disease
- independently from age, sex,
Key exclusion criteria (1 listed)
- Emergency colorectal resections
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Adherance to ERAS protocol
Time frame: 36 months
Number of items included in the ERAS protocols that were applied in each centre
1 secondary outcome
Number of items of the ERAS protol correlated wih adverse events as described by the Clavien Dindo Classification and with a longer hospital stay
Time frame: 36 months
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 9 Sep 2025.
- Background: PubMed 7891489Bardram L, Funch-Jensen P, Jensen P, Crawford ME, Kehlet H. Recovery after laparoscopic colonic surgery with epidural analgesia, and early oral nutrition and mobilisation. Lancet. 1995 Mar 25;345(8952):763-4. doi: 10.1016/s0140-6736(95)90643-6.
- 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 15896435Fearon KC, Ljungqvist O, Von Meyenfeldt M, Revhaug A, Dejong CH, Lassen K, Nygren J, Hausel J, Soop M, Andersen J, Kehlet H. Enhanced recovery after surgery: a consensus review of clinical care for patients undergoing colonic resection. Clin Nutr. 2005 Jun;24(3):466-77. doi: 10.1016/j.clnu.2005.02.002. Epub 2005 Apr 21.
- Background: PubMed 19841366Lassen K, Soop M, Nygren J, Cox PB, Hendry PO, Spies C, von Meyenfeldt MF, Fearon KC, Revhaug A, Norderval S, Ljungqvist O, Lobo DN, Dejong CH; Enhanced Recovery After Surgery (ERAS) Group. Consensus review of optimal perioperative care in colorectal surgery: Enhanced Recovery After Surgery (ERAS) Group recommendations. Arch Surg. 2009 Oct;144(10):961-9. doi: 10.1001/archsurg.2009.170.
- Background: PubMed 28097305Ljungqvist O, Scott M, Fearon KC. Enhanced Recovery After Surgery: A Review. JAMA Surg. 2017 Mar 1;152(3):292-298. doi: 10.1001/jamasurg.2016.4952.
- Background: PubMed 23052794Gustafsson UO, Scott MJ, Schwenk W, Demartines N, Roulin D, Francis N, McNaught CE, Macfie J, Liberman AS, Soop M, Hill A, Kennedy RH, Lobo DN, Fearon K, Ljungqvist O; 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 colonic surgery: Enhanced Recovery After Surgery (ERAS((R))) Society recommendations. World J Surg. 2013 Feb;37(2):259-84. doi: 10.1007/s00268-012-1772-0. No abstract available.
- Background: PubMed 18650627Kehlet H, Wilmore DW. Evidence-based surgical care and the evolution of fast-track surgery. Ann Surg. 2008 Aug;248(2):189-98. doi: 10.1097/SLA.0b013e31817f2c1a.
- Background: PubMed 16775831Wind J, Polle SW, Fung Kon Jin PH, Dejong CH, von Meyenfeldt MF, Ubbink DT, Gouma DJ, Bemelman WA; Laparoscopy and/or Fast Track Multimodal Management Versus Standard Care (LAFA) Study Group; Enhanced Recovery after Surgery (ERAS) Group. Systematic review of enhanced recovery programmes in colonic surgery. Br J Surg. 2006 Jul;93(7):800-9. doi: 10.1002/bjs.5384.
- Background: PubMed 19459015Eskicioglu C, Forbes SS, Aarts MA, Okrainec A, McLeod RS. Enhanced recovery after surgery (ERAS) programs for patients having colorectal surgery: a meta-analysis of randomized trials. J Gastrointest Surg. 2009 Dec;13(12):2321-9. doi: 10.1007/s11605-009-0927-2. Epub 2009 May 21.
- Background: PubMed 12880610Kondrup J, Allison SP, Elia M, Vellas B, Plauth M; Educational and Clinical Practice Committee, European Society of Parenteral and Enteral Nutrition (ESPEN). ESPEN guidelines for nutrition screening 2002. Clin Nutr. 2003 Aug;22(4):415-21. doi: 10.1016/s0261-5614(03)00098-0.
- Background: PubMed 12765673Kondrup J, Rasmussen HH, Hamberg O, Stanga Z; Ad Hoc ESPEN Working Group. Nutritional risk screening (NRS 2002): a new method based on an analysis of controlled clinical trials. Clin Nutr. 2003 Jun;22(3):321-36. doi: 10.1016/s0261-5614(02)00214-5.
- Background: PubMed 21451404Awad S, Lobo DN. What's new in perioperative nutritional support? Curr Opin Anaesthesiol. 2011 Jun;24(3):339-48. doi: 10.1097/ACO.0b013e328345865e.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Cancer and Diverticulum, Colon, run by PERSIANI ROBERTO at 1 site in Italy.
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 4 inclusion and 1 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 9 Sep 2025. 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 Italy. 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?
Adherance to ERAS protocol (time frame: 36 months). 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 NCT03353311, which also lists 49 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 9 Sep 2025.