Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

Study Overview
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Brief Summary
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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
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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.

Official Title
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Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care

Conditions
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Colorectal Surgery

Intervention / Treatment
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* Other: Clinical and economical evaluation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambulatory care<br>Colorectal surgery in ambulatory care | Other: Clinical and economical evaluation<br>* Evaluation of the clinical and the economical impact of a colorectal surgery<br>|
| Other: Standard hospitalization<br>Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching. | Other: Clinical and economical evaluation<br>* Evaluation of the clinical and the economical impact of a colorectal surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Mean hospital length of stay | Mean hospital length of stay for the standard hospitalization group | 2 years and 3 months | 
| Ambulatory colectomies rate | Rate of ambulatory colectomies compared to the total number of colectomies performed | 2 years and 3 months | 
| Ambulatory care failure rate | Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery | 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) | 2 years and 3 months | 
| Mean time period required for a postoperative complication care | Mean time period required for a postoperative complication care | 2 years and 3 months | 
| Hospital re-admissions rate | Rate of hospital re-admissions related to postoperative complications | 30 days | 
| Rate of complications (Morbidity) | Rate of complications related or not to surgery | 30 days | 
| Rate of death (Mortality) | Number of patients who died within the individual participation period | 30 days | 
| Complications rate | Clinical and economic evaluation of postoperative complications rates difference between ambulatory care group and standard hospitalization group | 30 days | 
| Complications severity classification | Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification | 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 | 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). | 2 years and 3 months | 
| Costs related to postoperative complications | Costs related to postoperative complications difference between ambulatory care group and standard hospitalization group | 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 | 2 years and 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colorectal surgery, Ambulatory care, Medical and economic evaluation