Outpatient Bariatric Surgery

Obesity, Morbid Clinical Trial

— Bariatric Ambu  

Official title:

Clinical and Economic Evaluation of Outpatient Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04423575
• Other study ID #: 19-011
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: February 23, 2021

Study information

• Verified date: March 2022
• Source: IHU Strasbourg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 23, 2021
• Est. primary completion date: February 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity, Morbid

Intervention

Other:
• Outpatient 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.

Locations

Country	Name	City	State
France	University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
IHU Strasbourg

Country where clinical trial is conducted

France, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean cost evaluation of health care pathway	Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology	from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
Secondary	Mean hospital length of stay	Mean hospital length of stay including readmission duration	from surgery to one month postoperatively
Secondary	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".	at day 0, day 7 and day 30 postoperatively
Secondary	Complication rate	rate of postoperative complications	from surgery to one month postoperatively
Secondary	Ambulatory failure rate	rate of patients in Arm 1 who spent at least the first night in the hospital	from surgery to one month postoperatively
Secondary	Readmission rate	rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0	from surgery to one month postoperatively
Secondary	Costs related to Complication	costs related to the postoperative complications will be assessed by micro-costing methodology	from surgery to one month postoperatively

External Links

•   Epidemiologic study on obesity in France, 2017
•   Epidemiologic study on obesity surgery in France, 2018
•   PMSI (Programme de médicalisation des systèmes d'information)