Postoperative PainPhase 3NCT03765827
Vitamin E on Staple Line and Anastomoses of Roux-en-Y Gastric Bypass
A Phase 3 study testing Vitamine E Acetate and No application of vitamin E acetate in people with Postoperative Pain, run by Hospital General Universitario Elche at 1 site in Spain.
Trial summary
Patients will be randomized into 2 groups: Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses Control group: Vitamin E will not be applied Postoperative pain will be assessed 24 hours after surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Vitamine E Acetate and No application of vitamin E acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteSpain
- Study dates
- 5 Dec 2018to 30 Apr 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- BMI >40 Kg/m2 or >35 Kg/m2 associated to obesity-related comorbidities
- Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
- Patients accepting to participate in the study and signing and Informed Consent form
Who cannot join
- Patients undergoing other bariatric techniques
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery.
Read the detailed description
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).
- Conditions
- Postoperative Pain
- Being tested
- Vitamine E Acetate, No application of vitamin E acetate
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamine E AcetateDrug
Also called Vitamin E acetate ointment
Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass
No application of vitamin E acetateDrug
Also called No application of vitamin E acetate oinment
Vitamin E acetate ointment will not be applied in this group
| Study group | Role | What they receive |
|---|---|---|
| Vitamin E acetate | Experimental | Vitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass Receives: Drug: Vitamine E Acetate |
| Control group | Sham comparator | No ointment will be applied Receives: Drug: No application of vitamin E acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
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 posted5 Dec 2018
- Study start5 Dec 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies 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
- 140 participants (actual)
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
- Damian Garcia, MD, PhD, Study director, Hospital Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03765827
- Sponsor's protocol ID
- HRJC 18-11
- Status last verified
- Feb 2020
- First submitted
- 4 Dec 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ruiz-Tovar J, Garcia A, Ferrigni C, Duran M. Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants. Obes Surg. 2020 Aug;30(8):2988-2993. doi: 10.1007/s11695-020-04635-9.
PubMed 32342266
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of the Application of Vitamin E Ointment, Over Staple Lines and Anastomosis in Roux-en-Y Gastric Bypass, on Postoperative Pain
- ClinicalTrials.gov ID
- NCT03765827
- Acronym / sponsor ID
- HRJC 18-11
- Conditions
- Postoperative Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 5 Dec 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.
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E ointment will be applied over staple lines and anastomoses
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery.
Detailed description
Patients will be randomized into 2 groups:
- Vit E group: Vitamin E acetate ointment will be applied over staple lines and anastomoses in Roux-en-Y gastric bypass.
- Control group: Vitamin E will not be applied
Postoperative pain will be assessed 24 hours after surgery, by means of visuala analogic scale (ranging from 0 to 100mm).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vitamin E acetate | Experimental | Drug: Vitamine E AcetateVitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass |
| Control group | Sham comparator | Drug: No application of vitamin E acetateNo ointment will be applied |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- BMI >40 Kg/m2 or >35 Kg/m2 associated to obesity-related comorbidities
- Patients undergoing Roux-en-Y gastric bypass as bariatric procedure
- Patients accepting to participate in the study and signing and Informed Consent form
Key exclusion criteria (2 listed)
- Patients undergoing other bariatric techniques
- Patients undergoing Roux-en-Y gastric bypass as revisional procedure
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 |
|---|---|---|
| Vitamine E AcetateAlso: Vitamin E acetate ointmentVitamin E acetate ointment will be applied over the staple lines and anastomoses in Roux-en-Y gastric bypass | Drug | Vitamin E acetate |
| No application of vitamin E acetateAlso: No application of vitamin E acetate oinmentVitamin E acetate ointment will not be applied in this group | Drug | Control group |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
Postoperative pain will be assessed by means of a Visual Analogic Scale, ranging from 0 (absence of pain) to100mm (unbearable pain)
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 17 Feb 2020.
- Derived from this study: PubMed 32342266Ruiz-Tovar J, Garcia A, Ferrigni C, Duran M. Application of Vitamin E Acetate on Staple Lines and Anastomoses of Roux-en-Y Gastric Bypass: Impact on Postoperative Pain and Acute Phase Reactants. Obes Surg. 2020 Aug;30(8):2988-2993. doi: 10.1007/s11695-020-04635-9.
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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.
Damian Garcia, MD, PhD study director
Hospital Rey Juan Carlos
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 Vitamine E Acetate and No application of vitamin E acetate in people with Postoperative Pain, 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 3 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: finished, as of the sponsor's last update on 17 Feb 2020. 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. Some participants in this study may receive a placebo. 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?
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?
Postoperative pain (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?
On the ClinicalTrials.gov record for NCT03765827, which also lists 1 linked publication.
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 17 Feb 2020.