Skip to content

Outpatient Bariatric Surgery

Clinical and Economic Evaluation of Outpatient Bariatric Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04423575
Acronym
Bariatric Ambu
Enrollment
60
Registered
2020-06-09
Start date
2020-06-09
Completion date
2021-02-23
Last updated
2022-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity, Morbid

Keywords

Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy

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.

Interventions

OTHEROutpatient health care pathway

A surgical procedure performed as an outpatient procedure means that the patient leaves the hospital before 8pm the same day. The surgery is identical but the standard care pathway is reinforced to insure a safe return to home.

Sponsors

IHU Strasbourg
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Mean cost evaluation of health care pathwayfrom the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointmentMean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology

Secondary

MeasureTime frameDescription
Mean hospital length of stayfrom surgery to one month postoperativelyMean hospital length of stay including readmission duration
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scaleat day 0, day 7 and day 30 postoperativelyThe 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.
Complication ratefrom surgery to one month postoperativelyrate of postoperative complications
Ambulatory failure ratefrom surgery to one month postoperativelyrate of patients in Arm 1 who spent at least the first night in the hospital
Readmission ratefrom surgery to one month postoperativelyrate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0
Costs related to Complicationfrom surgery to one month postoperativelycosts related to the postoperative complications will be assessed by micro-costing methodology

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026