Outpatient Bariatric Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2021-02-23

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Analysis of Changes in Eating Habits on Post Bariatric Surgery Patients and Their Family Members

NCT02431195

Obesity Bariatric Surgery

COMPLETED

Study of Bariatric Surgery

NCT02857179

Bariatric Surgery

RECRUITING

Financial Incentives and Weight Loss in Failed Bariatric Surgery

NCT06910735

Obesity Obesity Recidivism

NOT_YET_RECRUITING NA

Quality of Life Outcomes and Economic Impacts of Bariatric Surgery

NCT00850356

Obesity

COMPLETED

Impact of Functional Status on 30-day Resource Utilization and Organ System Complications Following Bariatric Surgery

NCT05917691

Dependence Perioperative/Postoperative Complications Frailty

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity, Morbid

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

Outpatient health care pathway

Intervention Type OTHER

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.

Inpatients

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No