Effect of Peritoneal Lavage With Clindamycin-gentamicin on Laparoscopic Sleeve Gastrectomy
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ClinicalTrials.gov Identifier: NCT02479971 |
Recruitment Status :
Completed
First Posted : June 24, 2015
Last Update Posted : June 24, 2015
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Condition or disease | Intervention/treatment | Phase |
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Pain | Drug: Clindamycin-gentamicin irrigation Drug: Normal saline irrigation | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Effect of Peritoneal Lavage With Clindamycin-gentamicin Solution on Postoperative Pain and Analytic Acute Phase Reactants Following Laparoscopic Sleeve Gastrectomy |
Study Start Date : | January 2014 |
Actual Primary Completion Date : | June 2015 |
Actual Study Completion Date : | June 2015 |

Arm | Intervention/treatment |
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Active Comparator: Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
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Drug: Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
Other Name: Saline irrigation |
Experimental: Clindamycin-gentamicin irrigation
An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed.
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Drug: Clindamycin-gentamicin irrigation
An irrigation of the entire abdominal cavity with 500 ml gentamicin-clindamycin solution will be performed.
Other Name: Clindamycin-gentamicin solution |
- Postoperative pain [ Time Frame: 24 hours after surgery ]Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery
- C reactive protein [ Time Frame: 24 hours after surgery ]C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02479971
Study Director: | Antonio Arroyo, MD, PhD | Hospital general Elche |
Responsible Party: | Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche |
ClinicalTrials.gov Identifier: | NCT02479971 |
Other Study ID Numbers: |
HGUE 2015-5 |
First Posted: | June 24, 2015 Key Record Dates |
Last Update Posted: | June 24, 2015 |
Last Verified: | June 2015 |
Clindamycin Clindamycin palmitate Clindamycin phosphate Gentamicins Anti-Bacterial Agents |
Anti-Infective Agents Protein Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |