Outpatient Bariatric Surgery (Bariatric Ambu)

March 28, 2022 updated by: IHU Strasbourg

Clinical and Economic Evaluation of Outpatient Bariatric Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 56 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Outpatients
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
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.
No Intervention: Inpatients
Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean cost evaluation of health care pathway
Time Frame: from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean hospital length of stay
Time Frame: from surgery to one month postoperatively
Mean hospital length of stay including readmission duration
from surgery to one month postoperatively
Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale
Time Frame: at day 0, day 7 and day 30 postoperatively

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
Complication rate
Time Frame: from surgery to one month postoperatively
rate of postoperative complications
from surgery to one month postoperatively
Ambulatory failure rate
Time Frame: from surgery to one month postoperatively
rate of patients in Arm 1 who spent at least the first night in the hospital
from surgery to one month postoperatively
Readmission rate
Time Frame: from surgery to one month postoperatively
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
Costs related to Complication
Time Frame: from surgery to one month postoperatively
costs related to the postoperative complications will be assessed by micro-costing methodology
from surgery to one month postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IHU Strasbourg

Investigators

  • Principal Investigator: Mihaela IGNAT, MD, PhD, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 9, 2020

Primary Completion (Actual)

February 23, 2021

Study Completion (Actual)

February 23, 2021

Study Registration Dates

First Submitted

June 5, 2020

First Submitted That Met QC Criteria

June 5, 2020

First Posted (Actual)

June 9, 2020

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Obesity, Morbid

Clinical Trials on Outpatient health care pathway

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe