Vomiting, PostoperativePhase 3NCT03104023
Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG
A Phase 3 study testing Staple line inversion and Staple line buttressing in people with Vomiting, Postoperative, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Vomiting, Postoperative
- What is being tested?
- Staple line inversion and Staple line buttressing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2017to Aug 2017
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- BMI >40
- BMI>35 with obesity-related comorbidities
Who cannot join
- Patients undergoing other bariatric techniques than sleeve gastrectomy
- Laparotomic approach
Trial locations and contacts
1 site in 1 country.
Lorea Zubiaga, MD, PhD contact
Maria Diez, MD, PhD contact
Spain1 site, 1 recruiting
- Recruiting
Hospital general Universitario de Elche
Elche, Alicante, 03202
Jaime Ruiz-Tovar, MD, PhD, 0034-630534808, jruiztovar@gmail.com
About this study
Official title: Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material
Postoperative nausea and vomits during the first 24 hours will be investigated.
Read the detailed description
Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).
Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.
- Conditions
- Vomiting, Postoperative
- Being tested
- Staple line inversion, Staple line buttressing
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staple line inversionProcedure or surgery
A staple line inversion will be performed with a running suture of Polypropylene 2/0
Staple line buttressingCombination product
The gastric section will be performed with a stapler with preloaded buttress material
| Study group | Role | What they receive |
|---|---|---|
| Staple line inversion | Active comparator | Patients will undergo a staple line inversion with a a running suture of Polypropylene 2/0. Receives: Procedure: Staple line inversion |
| Staple line buttressing | Experimental | The gastric section will be performed with preloaded buttress material . Receives: Combination Product: Staple line buttressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomits
Postoperative nausea and vomits will be measured using the postoperative nausea and vomiting intensity scale, described by Wengritzky et al (Br J Anaesth 2010;104:158-166). In this scale, the number of vomits are quantified, the frequence of nausea and if it is constant or varying are determined, and the duration of the feeling of nausea is established.
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study startJan 2017
- Primary completionAug 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vomiting, PostoperativeStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General Universitario Elche
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
- Investigators
- Jaime Ruiz-Tovar, Principal investigator, Hospital general Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03104023
- Sponsor's protocol ID
- HGUE 2016-33
- Status last verified
- Mar 2017
- First submitted
- 24 Mar 2017
- Last updated
- 27 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Staple Line Inversion vs Buttressing on Postoperative Nausea or Vomits After Laparoscopic Sleeve Gastrectomy (LSG)
- ClinicalTrials.gov ID
- NCT03104023
- Acronym / sponsor ID
- HGUE 2016-33
- Conditions
- Vomiting, Postoperative
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 7 Apr 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.
Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material
Postoperative nausea and vomits during the first 24 hours will be investigated.
Detailed description
Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).
Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staple line inversion | Active comparator | Procedure: Staple line inversionPatients will undergo a staple line inversion with a a running suture of Polypropylene 2/0. |
| Staple line buttressing | Experimental | Combination Product: Staple line buttressingThe gastric section will be performed with preloaded buttress material . |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >40
- BMI>35 with obesity-related comorbidities
Key exclusion criteria (2 listed)
- Patients undergoing other bariatric techniques than sleeve gastrectomy
- Laparotomic approach
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 |
|---|---|---|
| Staple line inversionA staple line inversion will be performed with a running suture of Polypropylene 2/0 | Procedure or surgery | Staple line inversion |
| Staple line buttressingThe gastric section will be performed with a stapler with preloaded buttress material | Combination product | Staple line buttressing |
Primary outcome
Postoperative nausea and vomits
Time frame: 24 hours after surgery
Postoperative nausea and vomits will be measured using the postoperative nausea and vomiting intensity scale, described by Wengritzky et al (Br J Anaesth 2010;104:158-166). In this scale, the number of vomits are quantified, the frequence of nausea and if it is constant or varying are determined, and the duration of the feeling of nausea is established.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Individual participant dataSharing planned: No
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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.
Lorea Zubiaga, MD, PhD contact
Maria Diez, MD, PhD contact
Jaime Ruiz-Tovar principal investigator
Hospital general Elche
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Staple line inversion and Staple line buttressing in people with Vomiting, Postoperative, run by Hospital General Universitario Elche at 1 site in Spain.
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 2 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: status not confirmed, as of the sponsor's last update on 27 Jun 2017. 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 Spain. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lorea Zubiaga, MD, PhD (obesidadhospitalgeneralelche@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomits (time frame: 24 hours after surgery). 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 27 Jun 2017.