Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
- Conditions
- Colorectal Surgery
- Interventions
- Other: Clinical and economical evaluation
- Registration Number
- NCT03760939
- Lead Sponsor
- IHU Strasbourg
- 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.
- 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 5
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Ambulatory care Clinical and economical evaluation Colorectal surgery in ambulatory care Standard hospitalization Clinical and economical evaluation Colorectal surgery with standard hospitalization for retrospective patients who benefit from the ERAS program, selected by statistical matching.
- Primary Outcome Measures
Name Time Method Mean cost evaluation 1 month Mean cost evaluation, for the hospital, of the ambulatory care compared with standard hospitalization for patients who benefit from the ERAS program.
- Secondary Outcome Measures
Name Time Method Mean time period required for a postoperative complication care 2 years and 3 months Mean time period required for a postoperative complication care
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale 7 and 30 days 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".Ambulatory care failure rate 2 years and 3 months Rate of patients scheduled for ambulatory care and non-discharged the evening of surgery
Complications rate 30 days Clinical and economic evaluation of postoperative complications rates difference between "ambulatory care" group and "standard hospitalization" group
Complications severity classification 30 days Clinical and economic evaluation of complications severity assessed by the Clavien-Dindo classification
Mean hospital length of stay 2 years and 3 months Mean hospital length of stay for the "standard hospitalization" group
Ambulatory colectomies rate 2 years and 3 months Rate of ambulatory colectomies compared to the total number of colectomies performed
Hospital re-admissions rate 30 days Rate of hospital re-admissions related to postoperative complications
Rate of complications (Morbidity) 30 days Rate of complications related or not to surgery
Rate of death (Mortality) 30 days Number of patients who died within the individual participation period
Evaluation of complication severity according to Clavien classification 2 years and 3 months 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"
Costs related to postoperative complications 2 years and 3 months Costs related to postoperative complications difference between "ambulatory care" group and "standard hospitalization" group
Duty desk call 2 years and 3 months Number of patients who called the duty desk (or for whom the duty desk has been called)
Mean additional hospital length of stay 2 years and 3 months 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).
Costs related to the management of postoperative complications 2 years and 3 months Overall costs are evaluated by individual costs of:
* unscheduled consultations,
* surgical treatment,
* medicated treatment
* hospitalisation's duration
Trial Locations
- Locations (1)
Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
🇫🇷Strasbourg, France