Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

NCT03760939 | Terminated

• 1 other identifier: 18-001
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colorectal Surgery

Keywords

Colorectal surgery; Ambulatory care; Medical and economic evaluation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale

  7 and 30 days

• Mean hospital length of stay

  2 years and 3 months

• Ambulatory colectomies rate

  2 years and 3 months

• Ambulatory care failure rate

  2 years and 3 months

• Duty desk call

  2 years and 3 months

Study Arms (2)

Ambulatory care

EXPERIMENTAL

Colorectal surgery in ambulatory care

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.

Other: Clinical and economical evaluation

Interventions

Clinical and economical evaluation OTHER

Evaluation of the clinical and the economical impact of a colorectal surgery

Ambulatory care; Standard hospitalization

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil

Strasbourg, 67091, France

Location

Related Publications (21)

• 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.

  PMID: 25661787 BACKGROUND

• 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.

  PMID: 27671006 BACKGROUND

• 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.

  PMID: 25650365 BACKGROUND

• 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.

  PMID: 16775831 BACKGROUND

• 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.

  PMID: 19207699 BACKGROUND

• 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.

  PMID: 19415308 BACKGROUND

• 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.

  PMID: 20116145 BACKGROUND

• 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.

  PMID: 21236454 BACKGROUND

• 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.

  PMID: 21328298 BACKGROUND

• 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.

  PMID: 27316295 BACKGROUND

• 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.

  PMID: 26913728 BACKGROUND

• 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.

  PMID: 23352608 BACKGROUND

• 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.

  PMID: 7891489 BACKGROUND

• 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.

  PMID: 19571699 BACKGROUND

• 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.

  PMID: 20734083 BACKGROUND

• 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.

  PMID: 23477191 BACKGROUND

• 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.

  PMID: 23925012 BACKGROUND

• 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.

  PMID: 24395115 BACKGROUND

• 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.

  PMID: 27863944 BACKGROUND

• 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.

  PMID: 24600507 BACKGROUND

• 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.

  PMID: 15273542 BACKGROUND

Study Officials

• Didier Mutter, MD, PhD

  Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2018
• First Posted: December 3, 2018
• Study Start: January 3, 2019
• Primary Completion: November 15, 2024
• Study Completion: November 15, 2024
• Last Updated: May 1, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)