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

Information source: Hospital General Universitario Elche
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Pain

Intervention: Clindamycin-gentamicin irrigation (Drug); Normal saline irrigation (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Hospital General Universitario Elche

Official(s) and/or principal investigator(s):
Antonio Arroyo, MD, PhD, Study Director, Affiliation: Hospital general Elche

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Prevention

Primary outcome: Postoperative pain

Secondary outcome: C reactive protein

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.

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

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.

Locations and Contacts

Additional Information

Starting date: January 2014
Last updated: June 22, 2015

Page last updated: August 23, 2015

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