Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy

Conditions
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Pain

Intervention / Treatment
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* Drug: Clindamycin-gentamicin irrigation
* Drug: Normal saline irrigation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Normal saline irrigation<br>An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed. | Drug: Normal saline irrigation<br>* An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.<br>* Other names: Saline irrigation;|
| Experimental: Clindamycin-gentamicin irrigation<br>An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed. | Drug: Clindamycin-gentamicin irrigation<br>* An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.<br>* Other names: Clindamycin-gentamicin solution;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein | C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery | 24 hours after surgery |