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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
Sponsor:
Information provided by (Responsible Party):
Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche

Brief 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 gentamicin-clindamycin solution (Group 2). Postoperative pain and C reactive protein will be investigated 24 hours after surgery.

Condition or disease Intervention/treatment Phase
Pain Drug: Clindamycin-gentamicin irrigation Drug: Normal saline irrigation Phase 3

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 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
Active Comparator: Normal saline irrigation
An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.
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.
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




Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 24 hours after surgery ]
    Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery


Secondary Outcome Measures :
  1. 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
Criteria

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.

Information from the National Library of Medicine

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


Sponsors and Collaborators
Hospital General Universitario Elche
Investigators
Study Director: Antonio Arroyo, MD, PhD Hospital general Elche

Responsible Party: Jaime Ruiz-Tovar, MD, PhD, Hospital General Universitario Elche
ClinicalTrials.gov Identifier: NCT02479971     History of Changes
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

Additional relevant MeSH terms:
Pharmaceutical Solutions
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Gentamicins
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action