Morbid ObesityPhase 2NCT03305432
Preoperative PPI in Sleeve Gastrectomy
A Phase 2 study testing sleeve + preoperative PPI in people with Morbid Obesity, run by Minia University at 1 site in Egypt.
Trial summary
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy Read more about this study
- Who is it for?
- Ages 16 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- sleeve + preoperative PPI
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2018to 20 Aug 2018
- Phase
- Phase 2
- 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 16 to 55 years
- All sexes
- Healthy volunteers accepted
- Child, 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 laparoscopic sleeve gastrectomy
- patients refuse to share in the study
- patients that already on PPI due to any indications
- revisional surgery for obesity
- previous upper abdominal surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Routine Preoperative PPI in Sleeve Gastrectomy
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy
Read the detailed description
In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not
- Conditions
- Morbid Obesity
- Being tested
- sleeve + preoperative PPI, sleeve + preoperative Placebo
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sleeve + preoperative PPICombination product
sleeve + preoperative PPI
sleeve + preoperative PlaceboCombination product
sleeve + preoperative Placebo
| Study group | Role | What they receive |
|---|---|---|
| PPI group | Experimental | take preoperative PPI for 10 days Receives: Combination Product: sleeve + preoperative PPI |
| Control group | Active comparator | take placebo for for 10 days preoperative Receives: Combination Product: sleeve + preoperative Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
early postoperative bleeding and leak
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
Measured: 2 weeks
Secondary outcomes (2)
operative time
time taken from skin incision to closure
Measured: 5 hours
microscopic picture of the removed stomach
histological examination to detect the presence of inflammation in of the removed part of the stomach
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 posted10 Oct 2017
- Study start15 Jan 2018
- Primary completion20 Aug 2018
- Study completion20 Aug 2018
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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305432
- Sponsor's protocol ID
- fac.med.043
- Status last verified
- Sep 2018
- First submitted
- 4 Oct 2017
- Last updated
- 5 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Routine Preoperative PPI in Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT03305432
- Acronym / sponsor ID
- fac.med.043
- Conditions
- Morbid Obesity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 20 Aug 2018 (actual)
- Study completion
- 20 Aug 2018 (actual)
- First posted
- 10 Oct 2017 (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.
he purpose of this study is to study the effect of preoperative PPI in the early outcome of sleeve gastrectomy
Detailed description
In this study 200 morbidly obese patients will be included and will be undergone sleeve gastrectomy. the patients will be randomly assigned into 2 groups, group 1 will be receive PPI preoperative for 10 day and group 2 will not
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PPI group | Experimental | Combination Product: sleeve + preoperative PPItake preoperative PPI for 10 days |
| Control group | Active comparator | Combination Product: sleeve + preoperative Placebotake placebo for for 10 days preoperative |
Who may qualify
- Ages
- 16 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, 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 (5 listed)
- Unfit patients for laparoscopic sleeve gastrectomy
- patients refuse to share in the study
- patients that already on PPI due to any indications
- 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 |
|---|---|---|
| sleeve + preoperative PPIsleeve + preoperative PPI | Combination product | PPI group |
| sleeve + preoperative Placebosleeve + preoperative Placebo | Combination product | Control group |
Primary outcome
early postoperative bleeding and leak
Time frame: 2 weeks
early postoperative complications, including bleeding from stable line either intragastric or intraperitoneal and early leak from stable line
2 secondary outcomes
operative time
Time frame: 5 hours
microscopic picture of the removed stomach
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 5 Sep 2018.
- 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.
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 Phase 2 study testing sleeve + preoperative PPI in people with Morbid Obesity, 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 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 5 Sep 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
early postoperative bleeding and leak (time frame: 2 weeks). 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 5 Sep 2018.