Clinical trial NCT03760939: Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
Official title: Clinical and Economical Evaluation of Colorectal Surgery in Ambulatory Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colorectal Surgery
Keywords: Colorectal surgery
Ambulatory care
Medical and economic evaluation
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2018-12-03
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mean cost evaluation
timeFrame: 1 month
Secondary outcomes:
measure: Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
timeFrame: 7 and 30 days
measure: Mean hospital length of stay
timeFrame: 2 years and 3 months
measure: Ambulatory colectomies rate
timeFrame: 2 years and 3 months
measure: Ambulatory care failure rate
timeFrame: 2 years and 3 months
measure: Duty desk call
timeFrame: 2 years and 3 months
measure: Mean time period required for a postoperative complication care
timeFrame: 2 years and 3 months
measure: Hospital re-admissions rate
timeFrame: 30 days
measure: Rate of complications (Morbidity)
timeFrame: 30 days
measure: Rate of death (Mortality)
timeFrame: 30 days
measure: Complications rate
timeFrame: 30 days
measure: Complications severity classification
timeFrame: 30 days
measure: Evaluation of complication severity according to Clavien classification
timeFrame: 2 years and 3 months
measure: Mean additional hospital length of stay
timeFrame: 2 years and 3 months
measure: Costs related to postoperative complications
timeFrame: 2 years and 3 months
measure: Costs related to the management of postoperative complications
timeFrame: 2 years and 3 months
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Service Chirurgie Digestive et Endocrinienne, Nouvel Hôpital Civil de Strasbourg
name: Didier Mutter, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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