PainPhase 3NCT02479971
Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy
A Phase 3 study testing Clindamycin-gentamicin irrigation and Normal saline irrigation in people with Pain, run by Hospital General Universitario Elche.
Trial summary
A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pain
- What is being tested?
- Clindamycin-gentamicin irrigation and Normal saline irrigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Jan 2014to Jun 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
- Body mass index (BMI) >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.
Who cannot join
- Gastroesophageal reflux
- Preoperative diagnosis of chronic renal failure
- Uncontrolled psychiatric disorders
- Active infections
- Malignancies
- Any other concomitant pathology considered as a contraindication for bariatric surgery.
About this study
Official title: Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy
A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
Read the detailed description
A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
- Conditions
- Pain
- Being tested
- Clindamycin-gentamicin irrigation, Normal saline irrigation
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clindamycin-gentamicin irrigationDrug
Also called Clindamycin-gentamicin solution
An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.
Normal saline irrigationDrug
Also called Saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Normal saline irrigation | Active comparator | An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed. Receives: Drug: Normal saline irrigation |
| Clindamycin-gentamicin irrigation | Experimental | An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed. Receives: Drug: Clindamycin-gentamicin irrigation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain
Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery
Measured: 24 hours after surgery
Secondary outcomes (1)
C reactive protein
C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery
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 posted24 Jun 2015 (estimated)
- Study startJan 2014
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Double blind
- Who is masked
- Participant, 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
- Antonio Arroyo, MD, PhD, Study director, Hospital general Elche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02479971
- Sponsor's protocol ID
- HGUE 2015-5
- Status last verified
- Jun 2015
- First submitted
- 17 Jun 2015
- Last updated
- 24 Jun 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT02479971
- Acronym / sponsor ID
- HGUE 2015-5
- 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
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jun 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.
A prospective, randomized study will be performed in patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
Detailed description
A prospective, randomized study will be performedin patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure. The patients will be randomized into 2 groups: those patients undergoing an intra-abdominal lavage with normal saline (Group 1) and those undergoing an intra-abdominal lavage with a gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal saline irrigation | Active comparator | Drug: Normal saline irrigationAn irrigation of the entire abdominal cavity with 500 ml normal saline will be performed. |
| Clindamycin-gentamicin irrigation | Experimental | Drug: Clindamycin-gentamicin irrigationAn irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index (BMI) >40 Kg/m2
- BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity
- Patients undergoing laparoscopic sleeve gastrectomy (LSG) as bariatric procedure.
Key exclusion criteria (6 listed)
- Gastroesophageal reflux
- Preoperative diagnosis of chronic renal failure
- Uncontrolled psychiatric disorders
- Active infections
- Malignancies
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 |
|---|---|---|
| Clindamycin-gentamicin irrigationAlso: Clindamycin-gentamicin solutionAn irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed. | Drug | Clindamycin-gentamicin irrigation |
| Normal saline irrigationAlso: Saline irrigationAn irrigation of the entire abdominal cavity with 500 ml normal saline will be performed. | Drug | Normal saline irrigation |
Primary outcome
Postoperative pain
Time frame: 24 hours after surgery
Postoperative pain will be evaluated by a Visual Analogic Scale 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 24 Jun 2015.
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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.
Antonio Arroyo, MD, PhD study director
Hospital general Elche
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Clindamycin-gentamicin irrigation and Normal saline irrigation 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 3 inclusion and 6 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 24 Jun 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. 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?
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 24 Jun 2015.