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Outpatient Bariatric Surgery (Bariatric Ambu)

Primary Purpose

Obesity, Morbid

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Outpatient health care pathway
Sponsored by
IHU Strasbourg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Obesity, Morbid focused on measuring Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Outpatients

Inpatients

Arm Description

Health care pathway: patient education, communication to liberal nurses, first-position surgical planning, bariatric surgery (bypass or sleeve) as outpatient procedure, follow-up by home nurse twice-a-day, standardized communication to surgeons, management of possible complications

Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Mean hospital length of stay
Mean hospital length of stay including readmission duration
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".
Complication rate
rate of postoperative complications
Ambulatory failure rate
rate of patients in Arm 1 who spent at least the first night in the hospital
Readmission rate
rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0
Costs related to Complication
costs related to the postoperative complications will be assessed by micro-costing methodology

Full Information

First Posted
June 5, 2020
Last Updated
March 28, 2022
Sponsor
IHU Strasbourg
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1. Study Identification

Unique Protocol Identification Number
NCT04423575
Brief Title
Outpatient Bariatric Surgery
Acronym
Bariatric Ambu
Official Title
Clinical and Economic Evaluation of Outpatient Bariatric Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
February 23, 2021 (Actual)
Study Completion Date
February 23, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHU Strasbourg

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Morbid
Keywords
Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Outpatients
Arm Type
Experimental
Arm Description
Health care pathway: patient education, communication to liberal nurses, first-position surgical planning, bariatric surgery (bypass or sleeve) as outpatient procedure, follow-up by home nurse twice-a-day, standardized communication to surgeons, management of possible complications
Arm Title
Inpatients
Arm Type
No Intervention
Arm Description
Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital)
Intervention Type
Other
Intervention Name(s)
Outpatient health care pathway
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean cost evaluation of health care pathway
Description
Mean costs related to the described health care pathway (outpatients vs inpatients) will be assessed by micro-costing methodology
Time Frame
from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
Secondary Outcome Measure Information:
Title
Mean hospital length of stay
Description
Mean hospital length of stay including readmission duration
Time Frame
from surgery to one month postoperatively
Title
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
Description
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".
Time Frame
at day 0, day 7 and day 30 postoperatively
Title
Complication rate
Description
rate of postoperative complications
Time Frame
from surgery to one month postoperatively
Title
Ambulatory failure rate
Description
rate of patients in Arm 1 who spent at least the first night in the hospital
Time Frame
from surgery to one month postoperatively
Title
Readmission rate
Description
rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0
Time Frame
from surgery to one month postoperatively
Title
Costs related to Complication
Description
costs related to the postoperative complications will be assessed by micro-costing methodology
Time Frame
from surgery to one month postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mihaela IGNAT, MD, PhD
Organizational Affiliation
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery
City
Strasbourg
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20077029
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.
Results Reference
background
PubMed Identifier
16192809
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.
Results Reference
background
PubMed Identifier
27901287
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.
Results Reference
background
PubMed Identifier
35689142
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.
Results Reference
derived
Links:
URL
https://www.santepubliquefrance.fr/determinants-de-sante/nutrition-et-activite-physique/documents/rapport-synthese/etude-de-sante-sur-l-environnement-la-biosurveillance-l-activite-physique-et-la-nutrition-esteban-2014-2016.-volet-nutrition.-chapitre-corpulence
Description
Epidemiologic study on obesity in France, 2017
URL
http://beh.santepubliquefrance.fr/beh/2018/5/pdf/2018_5_3.pdf
Description
Epidemiologic study on obesity surgery in France, 2018
URL
https://scansante.fr/applications/statistiques-activite-MCO-par-GHM
Description
PMSI (Programme de médicalisation des systèmes d'information)

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Outpatient Bariatric Surgery

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