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OpenTrials
Completed

NCT Number: NCT04423575

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery

Strasbourg, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Outpatient health care pathway

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.

Primary outcomes

  1. 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

Secondary outcomes

  1. Mean hospital length of stay

    Time frame: from surgery to one month postoperatively

    Mean hospital length of stay including readmission duration

  2. 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".

  3. Complication rate

    Time frame: from surgery to one month postoperatively

    rate of postoperative complications

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

IHU Strasbourg

Other

Registry information

Official study title

Clinical and Economic Evaluation of Outpatient Bariatric Surgery

Acronym: Bariatric Ambu

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jun 9, 2020
Registry last updated
Mar 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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