ObesityLSG-CTNCT03967860
Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy
An observational study of Obesity, run by Francesco De Cobelli at 1 site in Italy.
Trial summary
Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obesity
- What is being tested?
- CT scan
- How many people
- 250 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2019to 6 May 2019
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Obese patients with BMI ≥ 40 kg/m2 or between 35 e 40 kg/m2 with evidence of obesity related comorbidity
Who may be able to join
- adult obese patients with LSG
- BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2
- evidence of obesity related comorbidity
- availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery
Who cannot join
- Pregnant women
- allergy to contract medium
- lack of venous access
- patients who did not have a post-surgical upper abdomen CT
Trial locations and contacts
1 site in 1 country.
About this study
Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common.
The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.
- Conditions
- Obesity
- Being tested
- CT scan
- Keywords
- CT Scan
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT scanDiagnostic test
Post surgical standard CT Scan as predictor of complication
What is being measured
The primary outcome is the main question the study is designed to answer.
Value of Post surgery CT in identifying risks for subsequent development of gastric fistula
Measurements of: presence or abscence of fistula and site; presence/abscence of hematoma and site; presence/abscence of gastric torsion; Stapler to pylorus distance and stapler length
Measured: 72 hours post LSG
Secondary outcomes (1)
Post surgery risk
Risk stratification based on the correlation of the measurements obtained from the primary objective on outcome (complication vs non complication).
Measured: 72 hours post LSG
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2019
- Study start6 Mar 2019
- Primary completion6 May 2019
- Study completion6 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Francesco De Cobelli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francesco De Cobelli, IRCCS San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03967860
- Sponsor's protocol ID
- LSG-CT
- Acronym
- LSG-CT
- Status last verified
- Sep 2026
- First submitted
- 2 Apr 2019
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Post Surgery CT Following Laparoscopic Vertical Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03967860
- Acronym / sponsor ID
- LSG-CT / LSG-CT
- Conditions
- Obesity
- Keywords
- CT Scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Francesco De CobelliUniversity, hospital or other
- Study start
- 6 Mar 2019 (actual)
- Primary completion
- 6 May 2019 (actual)
- Study completion
- 6 May 2019 (actual)
- First posted
- 30 May 2019 (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.
Obesity is a extremely widespread condition in Europe and North America, burdened by a series of complications characterized by major morbidity and morbility. In recent years, bariatric surgery has progressively assumed a leading role in the treatment of morbid obesity and restrictive bariatric surgery procedures, such as laparoscopic vertical sleeve gastrectomy are common.
The aim of the study is to retrospectively determine the value of postoperative CT after LSG as an early tool to identify risk factors for the subsequent development of gastric fistula and enable to stratify postoperative risk in asymptomatic patients and ensure effective management of these risk factors.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Obese patients with BMI ≥ 40 kg/m2 or between 35 e 40 kg/m2 with evidence of obesity related comorbidity
Key inclusion criteria (4 listed)
- adult obese patients with LSG
- BMI ≥ 40 kg/m2 or BMI between 35 and 40 kg/m2
- evidence of obesity related comorbidity
- availability of upper abdomen CT scan with IV and oral contrast medium within 72 hours of surgery
Key exclusion criteria (4 listed)
- Pregnant women
- allergy to contract medium
- lack of venous access
- patients who did not have a post-surgical upper abdomen CT
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 |
|---|---|---|
| CT scanPost surgical standard CT Scan as predictor of complication | Diagnostic test | – |
Primary outcome
Value of Post surgery CT in identifying risks for subsequent development of gastric fistula
Time frame: 72 hours post LSG
Measurements of: presence or abscence of fistula and site; presence/abscence of hematoma and site; presence/abscence of gastric torsion; Stapler to pylorus distance and stapler length
1 secondary outcome
Post surgery risk
Time frame: 72 hours post LSG
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 23 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Obesity
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Active, not recruitingPhase 4
Effects of Sequential Therapy With Mexidol® (Intravenous) and Mexidol® FORTE 250 (Oral) on Functional Brain Activity Assessed by Functional Magnetic Resonance Imaging and Biochemical Parameters in Patients With Chronic Cerebral Ischemia: A Comparison of Patients With and Without Metabolic Disorders
Metabolic Abnormalities, Obesity & Overweight
Recruiting
Exercise Training and Vitamin D Metabolism
Obesity & Overweight, Vitamin D
Recruiting
Metabolic Health, Bones and Nuts During Weight Loss in Adults
Weight Loss, Bone Density
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by Francesco De Cobelli at 1 site in Italy.
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 4 inclusion and 4 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 23 Sep 2026. 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 Italy. 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?
Value of Post surgery CT in identifying risks for subsequent development of gastric fistula (time frame: 72 hours post LSG). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Sep 2026.