Clinical trial NCT04423575: Outpatient Bariatric Surgery
Official title: Clinical and Economic Evaluation of Outpatient Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity, Morbid
Keywords: Severe Obesity
Outpatient Surgery
Bariatric Surgery
Roux-en-Y Gastric Bypass
Sleeve Gastrectomy
Lead sponsor: IHU Strasbourg
Sponsor class: OTHER
First posted: 2020-06-09
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient). Then, the study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences.

Detailed description: This study first presents the organizational path and the health interventions included in the care episode for outpatient bariatric surgery, as compared to the health interventions usually performed in the care episode for bariatric surgery (including a conventional hospitalization with at least one-night inpatient).

This single-center, matched case-control study will be conducted in the Endocrine and Digestive Surgery Unit, Center of Excellence in Bariatric Surgery, of the University Hospital of Strasbourg. All the patients scheduled for bariatric procedures (Roux-en-Y gastric bypass and Sleeve Gastrectomy) and eligible for outpatient ambulatory procedures, will be checked for the inclusion criteria and will be asked if they accepted the outpatient bariatric procedure. If they accept, they will be included in the group A ("Outpatients"). At the end of the inclusion period, the patients in group A will be paired to patients who were operated in the same period, who had a conventional hospitalization and who will be matched based on the type of intervention, the age and the ASA status. These patients will form the group B ("Inpatients").

The integrated care pathway of the outpatients was formalized in order to secure this care pathway. It includes: patient education, enhanced rehabilitation program, first-position surgical planning, follow-up by home nurse twice-a-day, standardized communication to surgeons, and management of possible complications. All the health care interventions (anticipated or not) will be recorded for both groups.

The study aims to estimate and to compare the costs of bariatric surgery inpatient care episode to the costs of outpatient care episode, and also to evaluate the postoperative medical consequences. A cost-minimization analysis will be performed from the perspective of the healthcare provider. The direct costs of care production will be considered and estimated by a micro-costing methodology. The time horizon is set from the pre-operative outpatient appointment with the bariatric surgeon to the one-month post-operative appointment.

Eligibility criteria: Inclusion Criteria:

* Patient between the age of 18 and 60
* Patient with a BMI of more than 35 with comorbidities or BMI of more than 40
* Speaking and understanding French
* Access to a phone
* Access to a suitable healthcare facility near his residence
* Appropriate post-operative residence
* Moderate and/or controlled comorbidities
* Patient able to understand research objectives and risks and to give informed consent
* Patient not living alone
* affiliated to the French health insurance system

Exclusion Criteria:

* patient unable to provide informed consent
* Previous bariatric surgery
* Previous laparotomy
* BMI of more than 50
* Insulin-dependent diabetes
* Uncorrected preoperative anaemia
* Anticoagulation that cannot be interrupted
* Ischemic heart disease
* Untreated obstructive sleep apnea syndrome (OSA)
* dialysis
* Liver cirrhosis
* Subject under guardianship, curatorship, safeguarding/protection of justice
* Pregnancy
* Breastfeeding

Primary outcomes:
measure: Mean cost evaluation of health care pathway
timeFrame: from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
Secondary outcomes:
measure: Mean hospital length of stay
timeFrame: from surgery to one month postoperatively
measure: Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
timeFrame: at day 0, day 7 and day 30 postoperatively
measure: Complication rate
timeFrame: from surgery to one month postoperatively
measure: Ambulatory failure rate
timeFrame: from surgery to one month postoperatively
measure: Readmission rate
timeFrame: from surgery to one month postoperatively
measure: Costs related to Complication
timeFrame: from surgery to one month postoperatively
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery
Study officials:
affiliation: Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
name: Mihaela IGNAT, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cobourn C, Mumford D, Chapman MA, Wells L. Laparoscopic gastric banding is safe in outpatient surgical centers. Obes Surg. 2010 Apr;20(4):415-22. doi: 10.1007/s11695-009-0065-7.
citation: McCarty TM, Arnold DT, Lamont JP, Fisher TL, Kuhn JA. Optimizing outcomes in bariatric surgery: outpatient laparoscopic gastric bypass. Ann Surg. 2005 Oct;242(4):494-8; discussion 498-501. doi: 10.1097/01.sla.0000183354.66073.4c.
citation: Ignat M, Vix M, Imad I, D'Urso A, Perretta S, Marescaux J, Mutter D. Randomized trial of Roux-en-Y gastric bypass versus sleeve gastrectomy in achieving excess weight loss. Br J Surg. 2017 Feb;104(3):248-256. doi: 10.1002/bjs.10400. Epub 2016 Nov 30.
citation: Ignat M, Ansiaux J, Osailan S, D'Urso A, Morainvillers-Sigwalt L, Vix M, Mutter D. A Cost Analysis of Healthcare Episodes Including Day-Case Bariatric Surgery (Roux-en-Y Gastric Bypass and Sleeve Gastrectomy) Versus Inpatient Surgery. Obes Surg. 2022 Aug;32(8):2504-2511. doi: 10.1007/s11695-022-06144-3. Epub 2022 Jun 10.