Morbid ObesityNCT03938025
Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity
An observational study of Morbid Obesity, run by University of Rome Tor Vergata.
Trial summary
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric volume resected in sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 92 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2013to 30 Apr 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: final group from which data have been considered 92 patients (47females and 45 males)
Who may be able to join
- BMI over 60 kg/m2 in high-risk patients,
- BMI between 50 and 60 kg/m2 in nondiabetic patients,
- BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,
- patients with severe gastric inflammatory disease and H. pylori infection,
- patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding
Who cannot join
- severe and documented gastroesophageal reflux disease
- previous gastric surgery.
About this study
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.
- Conditions
- Morbid Obesity
- Being tested
- Gastric volume resected in sleeve gastrectomy
- Keywords
- Sleeve gastrectomy, Morbid obesity, Resected gastric volume
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric volume resected in sleeve gastrectomyProcedure or surgery
Misure of resected gastric volume and outcome
What is being measured
The primary outcome is the main question the study is designed to answer.
resected gastric volume in laparoscopic sleeve gastrectomy
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jan 2013
- Primary completion1 Jan 2017
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Morbid 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
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rome Tor Vergata
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Paolo Gentileschi, University of Rome Tor Vergata
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03938025
- Sponsor's protocol ID
- Gastric Volume Sleeve
- Status last verified
- May 2019
- First submitted
- 2 May 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
D'Ugo S, Bellato V, Bianciardi E, Gentileschi P. Impact of Resected Gastric Volume on Postoperative Weight Loss after Laparoscopic Sleeve Gastrectomy. Gastroenterol Res Pract. 2019 Dec 1;2019:3742075. doi: 10.1155/2019/3742075. eCollection 2019.
PubMed 31871448
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Resected Gastric Volume on Postoperative Weight Loss After Laparoscopic Sleeve Gastrectomy for Morbid Obesity
- ClinicalTrials.gov ID
- NCT03938025
- Acronym / sponsor ID
- Gastric Volume Sleeve
- Conditions
- Morbid Obesity
- Keywords
- Sleeve gastrectomy, Morbid obesity, Resected gastric volume
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- University of Rome Tor VergataUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 1 Jan 2017 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 6 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.
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity. Observational study with a mathematical method to approximate the calculation of the resected gastric volume after a sleeve gastrectomy and see the outcome on weight loss.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- final group from which data have been considered 92 patients (47females and 45 males)
Key inclusion criteria (5 listed)
- BMI over 60 kg/m2 in high-risk patients,
- BMI between 50 and 60 kg/m2 in nondiabetic patients,
- BMI between 40 and 50 kg/m2 in patients refusing a complex procedure like Roux-en-Y gastric bypass,
- patients with severe gastric inflammatory disease and H. pylori infection,
- patients with previous abdominal surgery involving the intestines, and young patients refusing gastric banding
Key exclusion criteria (2 listed)
- severe and documented gastroesophageal reflux disease
- previous gastric surgery.
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 |
|---|---|---|
| Gastric volume resected in sleeve gastrectomyMisure of resected gastric volume and outcome | Procedure or surgery | – |
Primary outcome
resected gastric volume in laparoscopic sleeve gastrectomy
Time frame: 5 years
Impact of resected gastric volume on postoperative weight loss after laparoscopic sleeve gastrectomy for morbid obesity
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 7 May 2019.
- Derived from this study: PubMed 31871448D'Ugo S, Bellato V, Bianciardi E, Gentileschi P. Impact of Resected Gastric Volume on Postoperative Weight Loss after Laparoscopic Sleeve Gastrectomy. Gastroenterol Res Pract. 2019 Dec 1;2019:3742075. doi: 10.1155/2019/3742075. eCollection 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Morbid Obesity, run by University of Rome Tor Vergata.
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 5 inclusion and 2 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 7 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
resected gastric volume in laparoscopic sleeve gastrectomy (time frame: 5 years). 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 NCT03938025, which also lists 1 linked publication.
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 7 May 2019.