Obesity, MorbidNCT05151107
Residual Gastric Area and Weight Loss After Sleeve Gastrectomy
An observational study of Obesity, Morbid, run by University of Foggia at 2 sites in Italy.
Trial summary
BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss after LSG. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA).
- How many people
- 56 participants
- Where
- 2 sitesItaly
- Study dates
- 1 Jul 2017to 1 Jul 2021
- 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 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 56 patients underwent sleeve gastrectomy with a mean age of 43,5± 11 years of which 40 were female.
Who may be able to join
- Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2
- Adult patients of both genders with morbid obesity defined as BMI>35 kg/m2 with at least one associated major comorbidity
Who cannot join
- Patients with secondary obesity due to endocrine and psychologic disorders
- Patients whit previous bariatric procedures
- Patients unwilling to comply with postoperative diet regimen and exercise program.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Relationship Between Residual Gastric Area and Weight Loss After Sleeve Gastrectomy: a Cohort Study
BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss after LSG.
MATERIALS AND METHODS: From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy.
UGI tract radiography was performed on day two after the operation to rule out leakage.
Read the detailed description
Study design and setting
From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy. UGI tract radiography with water-soluble contrast medium was performed on the second day after the operation to rule out leakage. The radiographic images were collected through a software program called "PACS" which combined with a viewer for image processing, allows for the calculation of the residual stomach area (RSA). RSA was correlated with postoperative weight (EWL) at 1, 6, and 12 months.
Eligibility criteria
Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2 or BMI>35 kg/m2 with at least one associated major comorbidity were included. We excluded patients with secondary obesity due to endocrine and psychological disorders, patients with previous bariatric procedures and patients unwilling to comply with postoperative diet and exercise program.
Statistical analysis
Continuous data were expressed as mean and standard deviation (SD) and they were analyzed using Student's T test. The correlation between gastric volume before and after LSG and BMI and weight loss was measured using Pearson correlation coefficient test. Correlation coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3 or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). P<0.05 was considered statistically significant. This work is fully compliant with the STROCSS criteria
- Conditions
- Obesity, Morbid
- Being tested
- The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA).
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA).Diagnostic test
Upper gastrointestinal radiographie
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative EWL % correlated with the Residual Stomach Area
the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss
Measured: 2017-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Jul 2017
- Primary completion1 Dec 2020
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanna Pavone, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151107
- Sponsor's protocol ID
- 1
- Status last verified
- Nov 2021
- First submitted
- 15 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Residual Gastric Area and Weight Loss After Sleeve Gastrectomy: a Cohort Study
- ClinicalTrials.gov ID
- NCT05151107
- Acronym / sponsor ID
- 1
- Conditions
- Obesity, Morbid
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 1 Dec 2020 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Dec 2021 (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.
BACKGROUND: The aim of this study is to evaluate the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss after LSG.
MATERIALS AND METHODS: From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy.
UGI tract radiography was performed on day two after the operation to rule out leakage.
Detailed description
Study design and setting
From May 2017 to December 2019, 56 patients with morbid obesity were admitted to the Department of Medical and Surgical Sciences, University of Foggia and underwent laparoscopic sleeve gastrectomy. UGI tract radiography with water-soluble contrast medium was performed on the second day after the operation to rule out leakage. The radiographic images were collected through a software program called "PACS" which combined with a viewer for image processing, allows for the calculation of the residual stomach area (RSA). RSA was correlated with postoperative weight (EWL) at 1, 6, and 12 months.
Eligibility criteria
Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2 or BMI>35 kg/m2 with at least one associated major comorbidity were included. We excluded patients with secondary obesity due to endocrine and psychological disorders, patients with previous bariatric procedures and patients unwilling to comply with postoperative diet and exercise program.
Statistical analysis
Continuous data were expressed as mean and standard deviation (SD) and they were analyzed using Student's T test. The correlation between gastric volume before and after LSG and BMI and weight loss was measured using Pearson correlation coefficient test. Correlation coefficients were classified as strong (-1.0 to -0.5 or 0.5 to 1.0), moderate (-0.5 to -0.3 or 0.3 to 0.5), and weak (-0.3 to -0.1 or 0.1 to 0.3). P<0.05 was considered statistically significant. This work is fully compliant with the STROCSS criteria
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 56 patients underwent sleeve gastrectomy with a mean age of 43,5± 11 years of which 40 were female.
Key inclusion criteria (2 listed)
- Adult patients of both genders with morbid obesity defined as BMI>40 kg/m2
- Adult patients of both genders with morbid obesity defined as BMI>35 kg/m2 with at least one associated major comorbidity
Key exclusion criteria (3 listed)
- Patients with secondary obesity due to endocrine and psychologic disorders
- Patients whit previous bariatric procedures
- Patients unwilling to comply with postoperative diet regimen and exercise program.
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 |
|---|---|---|
| The radiographic images were collected through a software called "PACS" which combined with a viewer for image processing, that allows the calculation of the residual stomach area (RSA).Upper gastrointestinal radiographie | Diagnostic test | – |
Primary outcome
Postoperative EWL % correlated with the Residual Stomach Area
Time frame: 2017-2019
the impact of the actual size and area of the remnant stomach, as measured by Upper gastrointestinal tract radiography, on weight loss
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 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, Morbid, run by University of Foggia at 2 sites 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 2 inclusion and 3 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 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Postoperative EWL % correlated with the Residual Stomach Area (time frame: 2017-2019). 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 9 Dec 2021.