ObesityGASTRAMBUNCT01513005
Feasibility of Laparoscopic Sleeve Gastrectomy in Day Case Surgery
A study testing Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity
- What is being tested?
- Laparoscopic Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- May 2011to May 2013
- 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
- sufficient understanding
- good observance of medical prescription
- availability of a responsible adult for the first operative night
- patients living nearby the hospital (1 h maximum away)
- telephonic accessibility
- between 18 and 60 years old adults
Show all 9Show fewer
- body mass index less than 60 kg/m2
- obesity requiring bariatric surgery
- surgery validated by an obesity-related staff
Who cannot join
- patient under administrative or legal protection
- obesity without HAS criteria
- cardiovascular comorbidity
- pulmonary comorbidity
- curative anticoagulant therapy
- bad diabetes control
- body mass index higher than 60 kg/m2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study
The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.
Read the detailed description
The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.
The sequence of this study is the following:
- patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
- medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
- during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
- after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
- the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
- the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
- follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
- Conditions
- Obesity
- Being tested
- Laparoscopic Sleeve Gastrectomy
- Keywords
- Laparoscopic Sleeve Gastrectomy, obesity management
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve GastrectomyProcedure or surgery
the operative technique consists in few steps:
- position of 4 trocars and insertion of a nasogastric tube
- dissection and mobilization of the greater curvature of the stomach
- preparation of the stomach for division
- gastric partition
- extraction of the gastric remnant
- postoperative surveillance
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Experimental | Not described Receives: Procedure: Laparoscopic Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
unexpected admission rate
the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.
Measured: the day following the surgery
Secondary outcomes (7)
readmission rate
the readmission rate is defined as the number of readmission with conventional hospitalization
Measured: one year
unexpected consultation rate
the unexpected consultation rate corresponds to the number of consultations after the Laparoscopic Sleeve Gastrectomy because of a postoperative outcome (adverse event, pain...)
Measured: one year
reoperation rate
Measured: one year
overall length of stay
the overall length of stay corresponds to the duration of all hospitalizations i.e. between the surgical procedure and the end of follow up.
Measured: one year
per operative outcomes
the per operative outcomes include each event observed during the surgical procedure
Measured: one year
postoperative outcomes
the postoperative outcomes include all outcomes reported during the follow-up period
Measured: one year
efficiency of Laparoscopic Sleeve Gastrectomy
the efficiency of Laparoscopic Sleeve Gastrectomy is evaluated with the BAROS questionnaire
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2012 (estimated)
- Study startMay 2011
- Primary completionMay 2012
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Marc REGIMBEAU, MD,phD, Principal investigator, CHU Amiens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01513005
- Sponsor's protocol ID
- PI10-PR.-REGIMBEAU
- Other IDs
- 2010-A01178-31
- Acronym
- GASTRAMBU
- Status last verified
- Sep 2025
- First submitted
- 16 Jan 2012
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.
PubMed 21769286Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
PubMed 20971049Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.
PubMed 19902316Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.
PubMed 19081482Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.
PubMed 18696169Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.
PubMed 27687352
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of Day Case Management by Laparoscopic Sleeve Gastrectomy for Obesity: a Pilot Study
- ClinicalTrials.gov ID
- NCT01513005
- Acronym / sponsor ID
- GASTRAMBU / PI10-PR.-REGIMBEAU
- Conditions
- Obesity
- Keywords
- Laparoscopic Sleeve Gastrectomy, obesity management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 20 Jan 2012 (estimated)
- 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.
The aim of this study is to determinate the feasibility of the Laparoscopic Sleeve Gastrectomy, a bariatric surgery i.e. a surgery as a treatment for obesity, could be proposed as a Day-Case surgery.
Detailed description
The purpose of this study is to investigate whether the patients with morbid obesity requiring a surgical approach by Laparoscopic Sleeve Gastrectomy could be operated according to a "day-case surgery" modality.
The sequence of this study is the following:
- patients consultation for bariatric management: during this consultation, the investigator is looking for exclusion criteria and prescribes laboratory tests.
- medical records of each patient are reviewed by an obesity-related staff: Laparoscopic Sleeve Gastrectomy is proposed.
- during a second consultation, the surgeon informed the patient about the proposition of the staff and his potential inclusion in this study
- after obtained his consent, the surgical procedure is planned and Laparoscopic Sleeve Gastrectomy is done in the Day-Case Surgery Unit.
- the following day the surgery, a nurse calls the patient to identify a potential postoperative outcome (nausea, vomiting, uncontrolled pain...)
- the 8th postoperative day, a consultation is done with laboratory tests and dietary follow-up.
- follow-up consultations are scheduled at 3, 6 and 12 months to evaluate the efficiency of the surgery procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- sufficient understanding
- good observance of medical prescription
- availability of a responsible adult for the first operative night
- patients living nearby the hospital (1 h maximum away)
- telephonic accessibility
Key exclusion criteria (7 listed)
- patient under administrative or legal protection
- obesity without HAS criteria
- cardiovascular comorbidity
- pulmonary comorbidity
- curative anticoagulant therapy
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 |
|---|---|---|
| Laparoscopic Sleeve Gastrectomythe operative technique consists in few steps: * position of 4 trocars and insertion of a nasogastric tube * dissection and mobilization of the greater curvature of the stomach * preparation of the stomach for division * gastric partition * extraction of the gastric remnant * postoperative surveillance | Procedure or surgery | Laparoscopic Sleeve Gastrectomy |
Primary outcome
unexpected admission rate
Time frame: the day following the surgery
the unexpected admission rate corresponds to the number of overnight hospitalization i.e. the number of patients not treated considering a Day-Case Surgery.
7 secondary outcomes
readmission rate
Time frame: one year
unexpected consultation rate
Time frame: one year
reoperation rate
Time frame: one year
overall length of stay
Time frame: one year
per operative outcomes
Time frame: one year
postoperative outcomes
Time frame: one year
efficiency of Laparoscopic Sleeve Gastrectomy
Time frame: six months
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 19 Sep 2025.
- Background: PubMed 21769286Pequignot A, Dhahria A, Mensah E, Verhaeghe P, Badaoui R, Sabbagh C, Regimbeau JM. Stapling and Section of the Nasogastric Tube during Sleeve Gastrectomy: How to Prevent and Recover? Case Rep Gastroenterol. 2011;5(2):350-4. doi: 10.1159/000329706. Epub 2011 Jul 6.
- Background: PubMed 20971049Dhahri A, Verhaeghe P, Hajji H, Fuks D, Badaoui R, Deguines JB, Regimbeau JM. Sleeve gastrectomy: technique and results. J Visc Surg. 2010 Oct;147(5 Suppl):e39-46. doi: 10.1016/j.jviscsurg.2010.08.016. No abstract available.
- Background: PubMed 19902316Sabbagh C, Verhaeghe P, Dhahri A, Brehant O, Fuks D, Badaoui R, Regimbeau JM. Two-year results on morbidity, weight loss and quality of life of sleeve gastrectomy as first procedure, sleeve gastrectomy after failure of gastric banding and gastric banding. Obes Surg. 2010 Jun;20(6):679-84. doi: 10.1007/s11695-009-0007-4. Epub 2009 Nov 10.
- Background: PubMed 19081482Fuks D, Verhaeghe P, Brehant O, Sabbagh C, Dumont F, Riboulot M, Delcenserie R, Regimbeau JM. Results of laparoscopic sleeve gastrectomy: a prospective study in 135 patients with morbid obesity. Surgery. 2009 Jan;145(1):106-13. doi: 10.1016/j.surg.2008.07.013. Epub 2008 Sep 30.
- Background: PubMed 18696169Fuks D, Dumont F, Berna P, Verhaeghe P, Sinna R, Sabbagh C, Demuynck F, Yzet T, Delcenserie R, Bartoli E, Regimbeau JM. Case report-complex management of a postoperative bronchogastric fistula after laparoscopic sleeve gastrectomy. Obes Surg. 2009 Feb;19(2):261-264. doi: 10.1007/s11695-008-9643-3. Epub 2008 Aug 12.
- Results publication: PubMed 27687352Badaoui R, Alami Chentoufi Y, Hchikat A, Rebibo L, Popov I, Dhahri A, Antoun G, Regimbeau JM, Lorne E, Dupont H. Outpatient laparoscopic sleeve gastrectomy: first 100 cases. J Clin Anesth. 2016 Nov;34:85-90. doi: 10.1016/j.jclinane.2016.03.026. Epub 2016 May 3.
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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.
Jean-Marc REGIMBEAU, MD,phD principal investigator
CHU Amiens
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic Sleeve Gastrectomy in people with Obesity, run by Centre Hospitalier Universitaire, Amiens 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 9 inclusion and 7 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 19 Sep 2025. 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?
unexpected admission rate (time frame: the day following the surgery). 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 NCT01513005, which also lists 6 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 19 Sep 2025.