PainPhase 3NCT02401399
Preoperative Diet Before Sleeve Gastrectomy
A Phase 3 study testing Regular diet, High protein formula and Immunonutrition in people with Pain, run by Hospital General Universitario Elche.
Trial summary
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Regular diet, High protein formula and Immunonutrition
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Feb 2015
- 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 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
Who cannot join
- gastroesophageal reflux
- patients with uncontrolled psychiatric disorders
- active infections or malignancies
- other concomitant pathology considered as a contraindication for bariatric surgery
About this study
Official title: Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
Read the detailed description
Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
- Conditions
- Pain
- Being tested
- Regular diet, High protein formula, Immunonutrition
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regular dietDietary supplement
The patients receive regular diet 900 Kcal/day during 15 days before surgery
High protein formulaDietary supplement
The patients receive high protein formula during 15 days before surgery
ImmunonutritionDietary supplement
The patients receive Immunonutrition formula during 15 days before surgery
| Study group | Role | What they receive |
|---|---|---|
| regular diet | Placebo comparator | The patients receive regular diet of 900 Kcal/day during 15 days before surgery Receives: Dietary Supplement: Regular diet |
| high protein formula | Active comparator | The patients receive high protein formula during 15 days before surgery Receives: Dietary Supplement: High protein formula |
| Immunonutrition | Experimental | The patients receive Immunonutrition during 15 days before surgery Receives: Dietary Supplement: Immunonutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Measured: 24 hours after surgery
Secondary outcomes (1)
C reactive protein
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 posted27 Mar 2015 (estimated)
- Study startJan 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 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
- Jaime Ruiz Tovar, Principal investigator, Hospital General Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02401399
- Sponsor's protocol ID
- HGUE15-2
- Status last verified
- Mar 2015
- First submitted
- 24 Mar 2015
- Last updated
- 27 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Ruiz-Tovar J, Zubiaga L, Diez M, Murcia A, Boix E, Munoz JL, Llavero C; OBELCHE group. Preoperative Regular Diet of 900 kcal/day vs Balanced Energy High-Protein Formula vs Immunonutrition Formula: Effect on Preoperative Weight Loss and Postoperative Pain, Complications and Analytical Acute Phase Reactants After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jun;26(6):1221-7. doi: 10.1007/s11695-015-1880-7.
PubMed 26358120
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02401399
- Acronym / sponsor ID
- HGUE15-2
- Conditions
- Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hospital General Universitario ElcheUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 27 Mar 2015 (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.
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
Detailed description
Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| regular diet | Placebo comparator | Dietary Supplement: Regular dietThe patients receive regular diet of 900 Kcal/day during 15 days before surgery |
| high protein formula | Active comparator | Dietary Supplement: High protein formulaThe patients receive high protein formula during 15 days before surgery |
| Immunonutrition | Experimental | Dietary Supplement: ImmunonutritionThe patients receive Immunonutrition during 15 days before surgery |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- BMI >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
Key exclusion criteria (4 listed)
- gastroesophageal reflux
- patients with uncontrolled psychiatric disorders
- active infections or malignancies
- other concomitant pathology considered as a contraindication for bariatric 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 |
|---|---|---|
| Regular dietThe patients receive regular diet 900 Kcal/day during 15 days before surgery | Dietary supplement | regular diet |
| High protein formulaThe patients receive high protein formula during 15 days before surgery | Dietary supplement | high protein formula |
| ImmunonutritionThe patients receive Immunonutrition formula during 15 days before surgery | Dietary supplement | Immunonutrition |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
1 secondary outcome
C reactive protein
Time frame: 24 hours after surgery
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 27 Mar 2015.
- Derived from this study: PubMed 26358120Ruiz-Tovar J, Zubiaga L, Diez M, Murcia A, Boix E, Munoz JL, Llavero C; OBELCHE group. Preoperative Regular Diet of 900 kcal/day vs Balanced Energy High-Protein Formula vs Immunonutrition Formula: Effect on Preoperative Weight Loss and Postoperative Pain, Complications and Analytical Acute Phase Reactants After Laparoscopic Sleeve Gastrectomy. Obes Surg. 2016 Jun;26(6):1221-7. doi: 10.1007/s11695-015-1880-7.
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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.
Jaime Ruiz Tovar principal investigator
Hospital General Elche
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Regular diet, High protein formula and Immunonutrition in people with Pain, run by Hospital General Universitario Elche.
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 4 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 27 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
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 NCT02401399, 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 27 Mar 2015.