Outpatient Bariatric Surgery

NCT04423575 | Completed

• 1 other identifier: 19-011
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Morbid

Keywords

Severe Obesity; Outpatient Surgery; Bariatric Surgery; Roux-en-Y Gastric Bypass; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Mean hospital length of stay

  from surgery to one month postoperatively

• Quality of life evaluation: EQ-5D (EuroQoL-5 Dimensions) scale

  at day 0, day 7 and day 30 postoperatively

• Complication rate

  from surgery to one month postoperatively

• Ambulatory failure rate

  from surgery to one month postoperatively

• Readmission rate

  from surgery to one month postoperatively

Study Arms (2)

Outpatients

EXPERIMENTAL

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

Inpatients

NO INTERVENTION

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

Interventions

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.

Outpatients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• IHU Strasbourg: lead

Study Sites (1)

University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery

Strasbourg, France

Location

Related Publications (4)

• 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.

  PMID: 20077029 BACKGROUND

• 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.

  PMID: 16192809 BACKGROUND

• 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.

  PMID: 27901287 BACKGROUND

• 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.

  PMID: 35689142 DERIVED

Related Links

• Epidemiologic study on obesity in France, 2017
• Epidemiologic study on obesity surgery in France, 2018

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihaela IGNAT, MD, PhD

  Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2020
• First Posted: June 9, 2020
• Study Start: June 9, 2020
• Primary Completion: February 23, 2021
• Study Completion: February 23, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)