Obesity, MorbidNCT03486691
Preoperative Ultrasound as a Predictor for Difficulty in Bariatric Surgery
A study testing Routine measurement of left lobe in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obesity, Morbid
- What is being tested?
- Routine measurement of left lobe
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 10 Aug 2018
- 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
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
Who cannot join
- Unfit patients for laparoscopy
- patients refuse to share in the study
- revisional surgery for obesity
- previous upper abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty
Read the detailed description
the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.
- Conditions
- Obesity, Morbid
- Being tested
- Routine measurement of left lobe, control group
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine measurement of left lobeOther
Routine preoperative measurement of left lobe
control groupOther
no routine preoperative measurement of left lobe
| Study group | Role | What they receive |
|---|---|---|
| preoperative left lobe measurement | Experimental | routine preoperative left lobe measurement Receives: Other: Routine measurement of left lobe |
| Control group | Active comparator | Control group without routine measurement of left lobe Receives: Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative maximum diameter of left lobe of the liver
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
Measured: 4 hours
score of difficulty
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time
Measured: 6 hours
Secondary outcomes (3)
operative time
operative time from skin to skin
Measured: 6 hours
incidence of intraoperative complications
incidence of intraoperative complications like bleeding,or injury to intra-abdominal organ
Measured: 3 days
early postoperative complications
early postoperative complications like leak or vomiting
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2018
- Study start1 Feb 2018
- Primary completion10 Aug 2018
- Study completion10 Aug 2018
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.
- More trials run by Minia 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa Mstafa Hassan Sewefy, Minia University
- Investigators
- Alaa M Sewefy, Principal investigator, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03486691
- Sponsor's protocol ID
- fac.med.055
- Status last verified
- Aug 2018
- First submitted
- 7 Mar 2018
- Last updated
- 16 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Ultrasonographic Liver Size as a Predictor for Difficulty in Bariatric Surgery
- ClinicalTrials.gov ID
- NCT03486691
- Acronym / sponsor ID
- fac.med.055
- Conditions
- Obesity, Morbid
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 10 Aug 2018 (actual)
- Study completion
- 10 Aug 2018 (actual)
- First posted
- 3 Apr 2018 (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.
the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty
Detailed description
the left lobe of the liver in obese patient usually fatty and enlarged and may cause difficulty during bariatric surgery. the aim of this study is to test the impact of routine preoperative ultrasound to evaluate the size of left lobe of the liver as a preoperative predictor for difficulty. two equal groups of patients are operated by laparoscopic sleeve gastrectomy with loop bipartition, in one group routine abdominal ultrasound is done, in the other group ultrasound not routinely done.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| preoperative left lobe measurement | Experimental | Other: Routine measurement of left loberoutine preoperative left lobe measurement |
| Control group | Active comparator | Other: control groupControl group without routine measurement of left lobe |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Morbidly obese patient with BMI more than 40 with or without co-morbidity
- Morbidly obese patient with BMI more than 35 with co-morbidity
Key exclusion criteria (4 listed)
- Unfit patients for laparoscopy
- patients refuse to share in the study
- revisional surgery for obesity
- previous upper abdominal 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 |
|---|---|---|
| Routine measurement of left lobeRoutine preoperative measurement of left lobe | Other | preoperative left lobe measurement |
| control groupno routine preoperative measurement of left lobe | Other | Control group |
Primary outcome
intraoperative maximum diameter of left lobe of the liver
Time frame: 4 hours
intraoperative maximum diameter of left lobe of the liver in centimeter using intraoperative tape
score of difficulty
Time frame: 6 hours
score of difficulty from:exposure of the hiatus, retraction of the liver and operative time
3 secondary outcomes
operative time
Time frame: 6 hours
incidence of intraoperative complications
Time frame: 3 days
early postoperative complications
Time frame: 2 weeks
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 16 Aug 2018.
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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.
Alaa M Sewefy principal investigator
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Routine measurement of left lobe in people with Obesity, Morbid, run by Minia 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 2 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 16 Aug 2018. 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?
intraoperative maximum diameter of left lobe of the liver (time frame: 4 hours). The study lists 2 primary outcomes in all. 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 16 Aug 2018.