Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

Colorectal Surgery Clinical Trial

— Colon-Ambu  

Official title:

Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03760939
• Other study ID #: 18-001
• Status: Recruiting
• Phase: N/A
• Start date: January 3, 2019
• Est. completion date: April 2024

Study information

• Verified date: January 2024
• Source: IHU Strasbourg
• Contact: Didier Mutter, MD, PhD
• Phone: +33(0)369550553
• Email: didier.mutter[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 140
• Est. completion date: April 2024
• Est. primary completion date: February 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• 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

Exclusion Criteria:

• 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)

• Hepatic cirrhosis

• Patient refusal

• Patient in custody

• Patient under guardianship

• Pregnancy

• Breastfeeding

• Poor general condition

Related Conditions & MeSH terms

• Colorectal Surgery

Intervention

Other:
• Clinical and economical evaluation
Evaluation of the clinical and the economical impact of a colorectal surgery

Locations

Country	Name	City	State
France	Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (21)

Adamina 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. — View Citation

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. — View Citation

Chasserant 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. — View Citation

Daams F, Wu Z, Lahaye MJ, Jeekel J, Lange JF. Prediction and diagnosis of colorectal anastomotic leakage: A systematic review of literature. World J Gastrointest Surg. 2014 Feb 27;6(2):14-26. doi: 10.4240/wjgs.v6.i2.14. — View Citation

Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae. — View Citation

Dobradin A, Ganji M, Alam SE, Kar PM. Laparoscopic colon resections with discharge less than 24 hours. JSLS. 2013 Apr-Jun;17(2):198-203. doi: 10.4293/108680813X13654754535791. — View Citation

Gash 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. — View Citation

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. — View Citation

Gouvas 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. — View Citation

Gustafsson 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. — View Citation

Lawrence 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. — View Citation

Levy 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. — View Citation

Martin-Ferrero MA, Faour-Martin O, Simon-Perez C, Perez-Herrero M, de Pedro-Moro JA. Ambulatory surgery in orthopedics: experience of over 10,000 patients. J Orthop Sci. 2014 Mar;19(2):332-338. doi: 10.1007/s00776-013-0501-3. Epub 2014 Jan 7. — View Citation

Rogers JP, Dobradin A, Kar PM, Alam SE. Overnight hospital stay after colon surgery for adenocarcinoma. JSLS. 2012 Apr-Jun;16(2):333-6. doi: 10.4293/108680812x13427982376789. — View Citation

Slim 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. — View Citation

Slim 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. — View Citation

Spanjersberg 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;(2):CD007635. doi: 10.1002/14651858.CD007635.pub2. — View Citation

Varadhan 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. — View Citation

Verrier JF, Paget C, Perlier F, Demesmay F. How to introduce a program of Enhanced Recovery after Surgery? The experience of the CAPIO group. J Visc Surg. 2016 Dec;153(6S):S33-S39. doi: 10.1016/j.jviscsurg.2016.10.001. Epub 2016 Nov 16. — View Citation

Walter 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. Erratum In: Colorectal Dis. 2010 Jul;12(7):728. — View Citation

Wind 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. — View Citation

* Note: There are 21 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 month
Secondary	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".	7 and 30 days
Secondary	Mean hospital length of stay	Mean hospital length of stay for the "standard hospitalization" group	2 years and 3 months
Secondary	Ambulatory colectomies rate	Rate of ambulatory colectomies compared to the total number of colectomies performed	2 years and 3 months
Secondary	Ambulatory care failure rate	Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery	2 years and 3 months
Secondary	Duty desk call	Number of patients who called the duty desk (or for whom the duty desk has been called)	2 years and 3 months
Secondary	Mean time period required for a postoperative complication care	Mean time period required for a postoperative complication care	2 years and 3 months
Secondary	Hospital re-admissions rate	Rate of hospital re-admissions related to postoperative complications	30 days
Secondary	Rate of complications (Morbidity)	Rate of complications related or not to surgery	30 days
Secondary	Rate of death (Mortality)	Number of patients who died within the individual participation period	30 days
Secondary	Complications rate	Clinical and economic evaluation of postoperative complications rates difference between "ambulatory care" group and "standard hospitalization" group	30 days
Secondary	Complications severity classification	Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification	30 days
Secondary	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"	2 years and 3 months
Secondary	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).	2 years and 3 months
Secondary	Costs related to postoperative complications	Costs related to postoperative complications difference between "ambulatory care" group and "standard hospitalization" group	2 years and 3 months
Secondary	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	2 years and 3 months

External Links

•   Haute Autorité de santé / Agence Nationale d'Appui à la Performance des établissements de santé et médico-sociaux, Ensemble pour le développement de la chirurgie ambulatoire, Socle de connaissances, Avril 2012
•   Haute Autorité de Santé, Construction d'un outil de micro-costing en chirurgie ambulatoire, Méthodologie et résultats des sites pilotes, Janvier 2015
•   Haute Autorité de Santé, Rapport d'orientation : Programmes de récupération améliorée après chirurgie (RAAC) : état des lieux et perspectives, Juin 2016
•   INSTRUCTION N° DGOS/R3/2015/296 du 28 septembre 2015 relative aux objectifs et orientations stratégiques du programme national de développement de la chirurgie ambulatoire pour la période 2015-2020