Obesity, MorbidNCT04826055
Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
A study testing biliary limb as fixed length and biliary limb as a percentage from small intestine length in people with Obesity, Morbid, run by Minia University at 1 site in Egypt.
Trial summary
in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length 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?
- biliary limb as fixed length and biliary limb as a percentage from small intestine length
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 1 siteEgypt
- Study dates
- 25 Mar 2021to 25 Mar 2022
- 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
- obese patients with BMI more than 40 or more than 35 with comorbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Who cannot join
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 35
- patient with previous upper abdominal surgery either for obesity or other diseases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: tp Make the Length of the Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length
Read the detailed description
in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length
- Conditions
- Obesity, Morbid
- Being tested
- biliary limb as fixed length, biliary limb as a percentage from small intestine length
- Keywords
- biliary limb length in bypass bariatric surgery
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biliary limb as fixed lengthOther
n all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature
biliary limb as a percentage from small intestine lengthOther
in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length
| Study group | Role | What they receive |
|---|---|---|
| loop bypass with fixed biliary limb length | Active comparator | in all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature Receives: Other: biliary limb as fixed length |
| loop bypass with a biliary limb is a percentage of the small intestine | Experimental | in all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length Receives: Other: biliary limb as a percentage from small intestine length |
What is being measured
The primary outcome is the main question the study is designed to answer.
effect on weight loss
the effect on weight loss
Measured: one year
effect on nutritional deficiency
the effect on nutritional deficiency
Measured: 1 year
Secondary outcomes (4)
operative time
operative time from skin incision to skin closure
Measured: 6 hours
effect on obesity comorbidities
the effect on improvement of obesity related comorbidities
Measured: 1 year
early complications
the operative and postoperative 30 days complications
Measured: 30 days
late complications
the late reported complications
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2021
- Study start25 Mar 2021
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 210 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04826055
- Sponsor's protocol ID
- fac.med 21.17
- Status last verified
- May 2022
- First submitted
- 29 Mar 2021
- Last updated
- 10 May 2022
- 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 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- tp Make the Length of the Biliary Limb as a Percentage From the Small Intestine Rather Than Fixed Length in Loop Bypass Surgery for Morbid Obesity
- ClinicalTrials.gov ID
- NCT04826055
- Acronym / sponsor ID
- fac.med 21.17
- Conditions
- Obesity, Morbid
- Keywords
- biliary limb length in bypass bariatric surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 25 Mar 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 1 Apr 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.
in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length. we do it as a percentage from total small intestine length rather than fixed length
Detailed description
in all loop bypass bariatric procedure (mini gastric bypass \& single anastomosis sleeve jejunal bypass), biliary limb is fixed length we count the length of small intestine and do it as a percentage from total small intestine length rather than fixed length
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| loop bypass with fixed biliary limb length | Active comparator | Other: biliary limb as fixed lengthin all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature |
| loop bypass with a biliary limb is a percentage of the small intestine | Experimental | Other: biliary limb as a percentage from small intestine lengthin all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- obese patients with BMI more than 40 or more than 35 with comorbidity
- patients fit for laparoscopic surgery
- give approval to share in the study
Key exclusion criteria (5 listed)
- patients refused to share in the study
- patients unfit for surgery
- patients aged less than 18 and older than 50
- patients with BMI less than 35
- patient with previous upper abdominal surgery either for obesity or other diseases
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 |
|---|---|---|
| biliary limb as fixed lengthn all loop bypass procedures we will don't count the total length of small intestine and make the biliary limb as a fixed from total small intestine length as mentioned in literature | Other | loop bypass with fixed biliary limb length |
| biliary limb as a percentage from small intestine lengthin all loop bypass procedures we count the total length of small intestine and make the biliary limb as a percentage from total small intestine length rather than fixed length | Other | loop bypass with a biliary limb is a percentage of the small intestine |
Primary outcome
effect on weight loss
Time frame: one year
the effect on weight loss
effect on nutritional deficiency
Time frame: 1 year
the effect on nutritional deficiency
4 secondary outcomes
operative time
Time frame: 6 hours
effect on obesity comorbidities
Time frame: 1 year
early complications
Time frame: 30 days
late complications
Time frame: 1 year
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 10 May 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing biliary limb as fixed length and biliary limb as a percentage from small intestine length 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 3 inclusion and 5 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 10 May 2022. 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?
effect on weight loss (time frame: one year). 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 10 May 2022.