Morbid ObesityNCT01846637
Two or Five cm From Pylorus During Laparoscopic Sleeve Gastrectomy
A study testing laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by Mansoura University at 1 site in Egypt.
Trial summary
The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- laparoscopic sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2010to May 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- morbid obese patients
Who cannot join
- contraindication to laparoscopy
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Gastroenterology Surgical Center
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy
The investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.
- Conditions
- Morbid Obesity
- Being tested
- laparoscopic sleeve gastrectomy
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sleeve gastrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| 2 cm from pylorus | Experimental | at laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus. Receives: Procedure: laparoscopic sleeve gastrectomy |
| 6 cm from pylorus | Active comparator | at laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus Receives: Procedure: laparoscopic sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of excess weight loss
Measured: 2 years
Secondary outcomes (1)
complications
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2013 (estimated)
- Study startJun 2010
- Primary completionApr 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdel-Raouf El-Geidie, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01846637
- Sponsor's protocol ID
- 2013
- Status last verified
- May 2013
- First submitted
- 10 Feb 2013
- Last updated
- 6 May 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Two and Five cm Resection During Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT01846637
- Acronym / sponsor ID
- 2013
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 3 May 2013 (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 investigators compare two techniques for laparoscopic sleeve gastrectomy. in the first one the distal margin of stapling is 2 cm from the pylorus and in the second it is 6 cm away from the pylorus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 2 cm from pylorus | Experimental | Procedure: laparoscopic sleeve gastrectomyat laparoscopic sleeve gastrectomy the distal point of gastric division is 2 cm from the pylorus. |
| 6 cm from pylorus | Active comparator | Procedure: laparoscopic sleeve gastrectomyat laparoscopic sleeve gastrectomy the distal point of gastric division is 6 cm from the pylorus |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- morbid obese patients
Key exclusion criteria (1 listed)
- contraindication to laparoscopy
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 |
|---|---|---|
| laparoscopic sleeve gastrectomy | Procedure or surgery | 2 cm from pylorus, 6 cm from pylorus |
Primary outcome
percentage of excess weight loss
Time frame: 2 years
1 secondary outcome
complications
Time frame: 2 years
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 6 May 2013.
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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 laparoscopic sleeve gastrectomy in people with Morbid Obesity, run by Mansoura 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 6 May 2013. 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?
percentage of excess weight loss (time frame: 2 years). 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 6 May 2013.