Obesity, MorbidBariatric AmbuNCT04423575
Outpatient Bariatric Surgery
A study testing Outpatient health care pathway in people with Obesity, Morbid, run by IHU Strasbourg at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Outpatient health care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2020to 23 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
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- 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
Who cannot join
- patient unable to provide informed consent
- Previous bariatric surgery
- Previous laparotomy
- BMI of more than 50
- Insulin-dependent diabetes
- Uncorrected preoperative anaemia
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
France1 site
University Hospital of Strasbourg, Department of Digestive and Endocrine Surgery
Strasbourg
About this study
Official title: 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.
Read the 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.
- Conditions
- Obesity, Morbid
- Being tested
- Outpatient health care pathway
- Keywords
- Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient health care pathwayOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from the pre-operative appointment with the bariatric surgeon to the one-month post-operative appointment
Secondary outcomes (6)
Mean hospital length of stay
Mean hospital length of stay including readmission duration
Measured: from surgery to one month postoperatively
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".
Measured: at day 0, day 7 and day 30 postoperatively
Complication rate
rate of postoperative complications
Measured: from surgery to one month postoperatively
Ambulatory failure rate
rate of patients in Arm 1 who spent at least the first night in the hospital
Measured: from surgery to one month postoperatively
Readmission rate
rate of patients in Arm 1 who were readmitted in the hospital, after being successful dismissed at day 0
Measured: from surgery to one month postoperatively
Costs related to Complication
costs related to the postoperative complications will be assessed by micro-costing methodology
Measured: from surgery to one month postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start9 Jun 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Obesity, MorbidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- IHU Strasbourg
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mihaela IGNAT, MD, PhD, Principal investigator, Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04423575
- Sponsor's protocol ID
- 19-011
- Acronym
- Bariatric Ambu
- Status last verified
- Mar 2022
- First submitted
- 5 Jun 2020
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 20077029McCarty 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.
PubMed 16192809Ignat 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.
PubMed 27901287Ignat 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.
PubMed 35689142
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Economic Evaluation of Outpatient Bariatric Surgery
- ClinicalTrials.gov ID
- NCT04423575
- Acronym / sponsor ID
- Bariatric Ambu / 19-011
- Conditions
- Obesity, Morbid
- Keywords
- Severe Obesity, Outpatient Surgery, Bariatric Surgery, Roux-en-Y Gastric Bypass, Sleeve Gastrectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- IHU StrasbourgUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Outpatients | Experimental | Other: Outpatient health care pathwayHealth 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 |
| Inpatients | No intervention | –Standard care pathway with bariatric surgery (bypass or sleeve) as inpatient procedure (at least one night in the hospital) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (14 listed)
- patient unable to provide informed consent
- Previous bariatric surgery
- Previous laparotomy
- BMI of more than 50
- Insulin-dependent diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient health care pathwayA 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. | Other | Outpatients |
Primary outcome
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
6 secondary outcomes
Mean hospital length of stay
Time frame: 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
Complication rate
Time frame: from surgery to one month postoperatively
Ambulatory failure rate
Time frame: from surgery to one month postoperatively
Readmission rate
Time frame: from surgery to one month postoperatively
Costs related to Complication
Time frame: from surgery to one month postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Background: PubMed 20077029Cobourn 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.
- Background: PubMed 16192809McCarty 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.
- Background: PubMed 27901287Ignat 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.
- Derived from this study: PubMed 35689142Ignat 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.
- Epidemiologic study on obesity in France, 2017Link provided by the sponsor.
- Epidemiologic study on obesity surgery in France, 2018Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mihaela IGNAT, MD, PhD principal investigator
Service de Chirurgie Digestive et Endocrinienne, NHC, Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Outpatient health care pathway in people with Obesity, Morbid, run by IHU Strasbourg at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04423575, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.