Colorectal SurgeryColon-AmbuNCT03760939
Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
A study testing Clinical and economical evaluation in people with Colorectal Surgery, run by IHU Strasbourg at 1 site in France.
Trial summary
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Clinical and economical evaluation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteFrance
- Study dates
- 3 Jan 2019to 15 Nov 2024
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female over 18 years old
- Patient able to understand the objectives and risks related to the trial
- Patient able to give written informed consent
- Patient able to understand and accept the health care program
- Isolated colonic lesion located on the colon or the upper rectum
- Any neoplastic or non-neoplastic colonic pathology
Show all 12Show fewer
- Colonic surgery except resection without continuity interruption (e.g. low cecum resection, partial colectomy, suture for polyp)
- Moderate and/or controlled comorbidities
- No history of multiple laparotomies
- No psychosocial distress
- No living alone patient
- Patient registered with the French social security
Who cannot join
- Patient in exclusion period of another clinical study
- Emergency surgical procedure
- Type 1 diabetes
- Presence of an uncontrolled preoperative anemia
- Effective anticoagulation treatment, impossible to suspend
- Kidney failure (treated by dialysis)
Show all 13Show fewer
- Hepatic cirrhosis
- Patient refusal
- Patient in custody
- Patient under guardianship
- Pregnancy
- Breastfeeding
- Poor general condition
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Strasbourg, 67091
About this study
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.
Read more
While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.
Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.
Read the detailed description
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors. Multiple interests have been shown:
- Equivalent mortality and/or morbidity compared with standard hospitalizations
- Medical and psychological benefits
- Individualized and less invasive health care pathways, in favor of patient's autonomy
- Multidisciplinary approach and innovative care
- Heath care costs management (decrease of hospital length of stay, optimization of operating rooms).
Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in few expert centers with significant experience (more than 100 patients in Le Havre and more than 85 patients in Lyon) but several human and organizational limitations slow this innovative care.
The risk of complications does not seem to be increased on condition of anticipate and provide a postoperative follow-up at home.
While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.
Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.
- Conditions
- Colorectal Surgery
- Being tested
- Clinical and economical evaluation
- Keywords
- Colorectal surgery, Ambulatory care, Medical and economic evaluation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical and economical evaluationOther
Evaluation of the clinical and the economical impact of a colorectal surgery
| Study group | Role | What they receive |
|---|---|---|
| Ambulatory care | Experimental | Colorectal surgery in ambulatory care Receives: Other: Clinical and economical evaluation |
| Standard hospitalization | Other | Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching. Receives: Other: Clinical and economical evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean cost evaluation
Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
Measured: 1 month
Secondary outcomes (15)
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
The EQ-5D Quality of Life scale consists of :
(i) a descriptive system, consists in 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, extreme problems.
(ii) a visual analog scale, records the respondent's self-rated health on a vertical, visual analogue scale where the endpoints are labelled 'Best imaginable health state" and "Worst imaginable health state".
Measured: 7 and 30 days
Mean hospital length of stay
Mean hospital length of stay for the "standard hospitalization" group
Measured: 2 years and 3 months
Ambulatory colectomies rate
Rate of ambulatory colectomies compared to the total number of colectomies performed
Measured: 2 years and 3 months
Ambulatory care failure rate
Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery
Measured: 2 years and 3 months
Duty desk call
Number of patients who called the duty desk (or for whom the duty desk has been called)
Measured: 2 years and 3 months
Mean time period required for a postoperative complication care
Mean time period required for a postoperative complication care
Measured: 2 years and 3 months
Hospital re-admissions rate
Rate of hospital re-admissions related to postoperative complications
Measured: 30 days
Rate of complications (Morbidity)
Rate of complications related or not to surgery
Measured: 30 days
Rate of death (Mortality)
Number of patients who died within the individual participation period
Measured: 30 days
Complications rate
Clinical and economic evaluation of postoperative complications rates difference between "ambulatory care" group and "standard hospitalization" group
Measured: 30 days
Complications severity classification
Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification
Measured: 30 days
Evaluation of complication severity according to Clavien classification
Severity of the complications will be evaluated according to the Clavien classification from Grade I "Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions" to Grade V "Death of a patient"
Measured: 2 years and 3 months
Mean additional hospital length of stay
Clinical and economic evaluation of hospital length of stay related to complications difference between "ambulatory care" group and "standard hospitalization" group (additional hospitalizations, extension of hospitalization or new hospitalization).
Measured: 2 years and 3 months
Costs related to postoperative complications
Costs related to postoperative complications difference between "ambulatory care" group and "standard hospitalization" group
Measured: 2 years and 3 months
Costs related to the management of postoperative complications
Overall costs are evaluated by individual costs of:
- unscheduled consultations,
- surgical treatment,
- medicated treatment
- hospitalisation's duration
Measured: 2 years and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2018
- Study start3 Jan 2019
- Primary completion15 Nov 2024
- Study completion15 Nov 2024
Why it stopped: Inclusion difficulties
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Didier Mutter, MD, PhD, Principal investigator, Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03760939
- Sponsor's protocol ID
- 18-001
- Acronym
- Colon-Ambu
- Status last verified
- Apr 2025
- First submitted
- 29 Nov 2018
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.
PubMed 25661787Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.
PubMed 27671006Slim K; Groupe GRACE (Groupe francophone de rehabilitation amelioree apres chirurgie); Amalberti R. Ambulatory colectomy: no innovation without evaluation. J Visc Surg. 2015 Feb;152(1):1-3. doi: 10.1016/j.jviscsurg.2015.01.001. Epub 2015 Jan 31. No abstract available.
PubMed 25650365Wind 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 16775831Walter CJ, Collin J, Dumville JC, Drew PJ, Monson JR. Enhanced recovery in colorectal resections: a systematic review and meta-analysis. Colorectal Dis. 2009 May;11(4):344-53. doi: 10.1111/j.1463-1318.2009.01789.x. Epub 2009 Feb 4.
PubMed 19207699Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.
PubMed 19415308Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
PubMed 20116145Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
PubMed 21236454Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
PubMed 21328298Slim K, Delaunay L, Joris J, Leonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de rehabilitation amelioree apres chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. No abstract available.
PubMed 27316295Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.
PubMed 26913728Lawrence JK, Keller DS, Samia H, Ermlich B, Brady KM, Nobel T, Stein SL, Delaney CP. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013 Mar;216(3):390-4. doi: 10.1016/j.jamcollsurg.2012.12.014. Epub 2013 Jan 23.
PubMed 23352608Bardram 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 7891489Levy BF, Scott MJ, Fawcett WJ, Rockall TA. 23-hour-stay laparoscopic colectomy. Dis Colon Rectum. 2009 Jul;52(7):1239-43. doi: 10.1007/DCR.0b013e3181a0b32d.
PubMed 19571699Gash KJ, Goede AC, Chambers W, Greenslade GL, Dixon AR. Laparoendoscopic single-site surgery is feasible in complex colorectal resections and could enable day case colectomy. Surg Endosc. 2011 Mar;25(3):835-40. doi: 10.1007/s00464-010-1275-8. Epub 2010 Aug 24.
PubMed 20734083
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
- ClinicalTrials.gov ID
- NCT03760939
- Acronym / sponsor ID
- Colon-Ambu / 18-001
- Conditions
- Colorectal Surgery
- Keywords
- Colorectal surgery, Ambulatory care, Medical and economic evaluation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inclusion difficulties
- Enrolment
- 5 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 3 Jan 2019 (actual)
- Primary completion
- 15 Nov 2024 (actual)
- Study completion
- 15 Nov 2024 (actual)
- First posted
- 3 Dec 2018 (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) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors.
While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.
Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.
Detailed description
Enhanced recovery after surgery (ERAS) significantly decreases mortality, morbidity and hospital length of stay without increasing the rate of re-hospitalization. It reduces psychologic stress caused by surgery and decreases postoperative complications about 50 %, especially in colorectal surgery. ERAS is now the object of several Good Practices Recommendations and is about to become the reference strategy.
The development of ambulatory surgery is a French national concern. Its interest has been demonstrated in many surgical fields. It requires a reflection centered on the patient and a health care pathway organization involving all health care actors. Multiple interests have been shown:
- Equivalent mortality and/or morbidity compared with standard hospitalizations
- Medical and psychological benefits
- Individualized and less invasive health care pathways, in favor of patient's autonomy
- Multidisciplinary approach and innovative care
- Heath care costs management (decrease of hospital length of stay, optimization of operating rooms).
Ambulatory colectomies feasibility is recognized since 2013-2014 in France (Dr. Gignoux, MD in Lyon and Dr. Chasserant, MD in Le Havre). These ambulatory procedures are implemented in few expert centers with significant experience (more than 100 patients in Le Havre and more than 85 patients in Lyon) but several human and organizational limitations slow this innovative care.
The risk of complications does not seem to be increased on condition of anticipate and provide a postoperative follow-up at home.
While hospitalization is still the standard practice for colonic surgery, the objective of this study is to evaluate the medical and economic impact of an ambulatory care for colorectal surgery.
Ambulatory care will be compared to standard hospitalization of patients who benefit from the ERAS program.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ambulatory care | Experimental | Other: Clinical and economical evaluationColorectal surgery in ambulatory care |
| Standard hospitalization | Other | Other: Clinical and economical evaluationColorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Male or female over 18 years old
- Patient able to understand the objectives and risks related to the trial
- Patient able to give written informed consent
- Patient able to understand and accept the health care program
- Isolated colonic lesion located on the colon or the upper rectum
Key exclusion criteria (13 listed)
- Patient in exclusion period of another clinical study
- Emergency surgical procedure
- Type 1 diabetes
- Presence of an uncontrolled preoperative anemia
- Effective anticoagulation treatment, impossible to suspend
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 |
|---|---|---|
| Clinical and economical evaluationEvaluation of the clinical and the economical impact of a colorectal surgery | Other | Ambulatory care, Standard hospitalization |
Primary outcome
Mean cost evaluation
Time frame: 1 month
Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
15 secondary outcomes
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
Time frame: 7 and 30 days
Mean hospital length of stay
Time frame: 2 years and 3 months
Ambulatory colectomies rate
Time frame: 2 years and 3 months
Ambulatory care failure rate
Time frame: 2 years and 3 months
Duty desk call
Time frame: 2 years and 3 months
Mean time period required for a postoperative complication care
Time frame: 2 years and 3 months
Hospital re-admissions rate
Time frame: 30 days
Rate of complications (Morbidity)
Time frame: 30 days
Rate of death (Mortality)
Time frame: 30 days
Complications rate
Time frame: 30 days
Complications severity classification
Time frame: 30 days
Evaluation of complication severity according to Clavien classification
Time frame: 2 years and 3 months
Mean additional hospital length of stay
Time frame: 2 years and 3 months
Costs related to postoperative complications
Time frame: 2 years and 3 months
Costs related to the management of postoperative complications
Time frame: 2 years and 3 months
Results and safety
The study was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Background: PubMed 25661787Gignoux B, Pasquer A, Vulliez A, Lanz T. Outpatient colectomy within an enhanced recovery program. J Visc Surg. 2015 Feb;152(1):11-5. doi: 10.1016/j.jviscsurg.2014.12.004. Epub 2015 Feb 7.
- Background: PubMed 27671006Chasserant P, Gosgnach M. Improvement of peri-operative patient management to enable outpatient colectomy. J Visc Surg. 2016 Nov;153(5):333-337. doi: 10.1016/j.jviscsurg.2016.07.006. Epub 2016 Sep 23.
- Background: PubMed 25650365Slim K; Groupe GRACE (Groupe francophone de rehabilitation amelioree apres chirurgie); Amalberti R. Ambulatory colectomy: no innovation without evaluation. J Visc Surg. 2015 Feb;152(1):1-3. doi: 10.1016/j.jviscsurg.2015.01.001. Epub 2015 Jan 31. No abstract available.
- 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 19207699Walter CJ, Collin J, Dumville JC, Drew PJ, Monson JR. Enhanced recovery in colorectal resections: a systematic review and meta-analysis. Colorectal Dis. 2009 May;11(4):344-53. doi: 10.1111/j.1463-1318.2009.01789.x. Epub 2009 Feb 4.
- Background: PubMed 19415308Gouvas N, Tan E, Windsor A, Xynos E, Tekkis PP. Fast-track vs standard care in colorectal surgery: a meta-analysis update. Int J Colorectal Dis. 2009 Oct;24(10):1119-31. doi: 10.1007/s00384-009-0703-5. Epub 2009 May 5.
- Background: PubMed 20116145Varadhan KK, Neal KR, Dejong CH, Fearon KC, Ljungqvist O, Lobo DN. The enhanced recovery after surgery (ERAS) pathway for patients undergoing major elective open colorectal surgery: a meta-analysis of randomized controlled trials. Clin Nutr. 2010 Aug;29(4):434-40. doi: 10.1016/j.clnu.2010.01.004. Epub 2010 Jan 29.
- Background: PubMed 21236454Adamina M, Kehlet H, Tomlinson GA, Senagore AJ, Delaney CP. Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery. Surgery. 2011 Jun;149(6):830-40. doi: 10.1016/j.surg.2010.11.003. Epub 2011 Jan 14.
- Background: PubMed 21328298Spanjersberg WR, Reurings J, Keus F, van Laarhoven CJ. Fast track surgery versus conventional recovery strategies for colorectal surgery. Cochrane Database Syst Rev. 2011 Feb 16;2011(2):CD007635. doi: 10.1002/14651858.CD007635.pub2.
- Background: PubMed 27316295Slim K, Delaunay L, Joris J, Leonard D, Raspado O, Chambrier C, Ostermann S; Le Groupe francophone de rehabilitation amelioree apres chirurgie (GRACE). How to implement an enhanced recovery program? Proposals from the Francophone Group for enhanced recovery after surgery (GRACE). J Visc Surg. 2016 Dec;153(6S):S45-S49. doi: 10.1016/j.jviscsurg.2016.05.008. Epub 2016 Jun 14. No abstract available.
- Background: PubMed 26913728Gustafsson UO, Oppelstrup H, Thorell A, Nygren J, Ljungqvist O. Adherence to the ERAS protocol is Associated with 5-Year Survival After Colorectal Cancer Surgery: A Retrospective Cohort Study. World J Surg. 2016 Jul;40(7):1741-7. doi: 10.1007/s00268-016-3460-y.
- Background: PubMed 23352608Lawrence JK, Keller DS, Samia H, Ermlich B, Brady KM, Nobel T, Stein SL, Delaney CP. Discharge within 24 to 72 hours of colorectal surgery is associated with low readmission rates when using Enhanced Recovery Pathways. J Am Coll Surg. 2013 Mar;216(3):390-4. doi: 10.1016/j.jamcollsurg.2012.12.014. Epub 2013 Jan 23.
- Individual participant dataSharing planned: No
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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.
Didier Mutter, MD, PhD principal investigator
Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical and economical evaluation in people with Colorectal Surgery, run by IHU Strasbourg at 1 site in France.
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 12 inclusion and 13 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: stopped early, as of the sponsor's last update on 1 May 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 France. 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 was stopped early (reason given: Inclusion difficulties). Results are not available in the source record.
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?
Mean cost evaluation (time frame: 1 month). 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 NCT03760939, which also lists 21 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 1 May 2025.