Bariatric Surgery ProceduresNCT02976649
Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery
An observational study of Bariatric Surgery Procedures, run by Ain Shams University at 1 site in Egypt.
Trial summary
The purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Bariatric Surgery Procedures
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- Jan 2016to Jun 2016
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Morbid obese patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass.
Who may be able to join
- patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass during the period from January to June 2016.
Who cannot join
- Patients were excluded in case of postoperative surgical complications, conversion to open surgery or in case of redo.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission.
Read the detailed description
A multi-dimensional score of 7 risk factors was proposed which may help in identifying morbidly obese patients undergoing bariatric surgeries who will need admission to a critical care unit postoperatively for follow up.
- Conditions
- Bariatric Surgery Procedures
- Keywords
- Morbid obesity, Bariatric surgery, Multi-dimensional score
- Medical subject headings
- Obesity, Morbid
What is being measured
The primary outcome is the main question the study is designed to answer.
Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission
Measured: Through study completion, an average of six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJun 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric Surgery ProceduresStudies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Nofal, Ain Shams University
- Investigators
- Walid H. Nofal, MD, Principal investigator, Anesthesiology department, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02976649
- Sponsor's protocol ID
- FMASU R 19/2016
- Status last verified
- Jul 2019
- First submitted
- 22 Nov 2016
- Last updated
- 29 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal of a Score to Detect the Need for Postoperative Intensive Care Unit Admission After Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02976649
- Acronym / sponsor ID
- FMASU R 19/2016
- Conditions
- Bariatric Surgery Procedures
- Keywords
- Morbid obesity, Bariatric surgery, Multi-dimensional score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 29 Nov 2016 (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 purpose of this study is to propose a multi-dimensional score to predict those patients undergoing bariatric surgeries who will be in need for postoperative ICU admission.
Detailed description
A multi-dimensional score of 7 risk factors was proposed which may help in identifying morbidly obese patients undergoing bariatric surgeries who will need admission to a critical care unit postoperatively for follow up.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Morbid obese patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass.
Key inclusion criteria (1 listed)
- patients who have been operated upon for either laparoscopic gastric sleeve or laparoscopic gastric bypass during the period from January to June 2016.
Key exclusion criteria (1 listed)
- Patients were excluded in case of postoperative surgical complications, conversion to open surgery or in case of redo.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission
Time frame: Through study completion, an average of 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 29 Jul 2019.
- 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.
Walid H. Nofal, MD principal investigator
Anesthesiology department, Faculty of Medicine, Ain Shams University
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 Bariatric Surgery Procedures, run by Ain Shams University at 1 site in Egypt.
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 1 inclusion and 1 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 Jul 2019. 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 Egypt. 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?
Creation of a multi-dimensional score for the need of post-bariatric surgery ICU admission (time frame: Through study completion, an average of six months.). 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 29 Jul 2019.