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

Phase 3

Completed

• Conditions: Pain
• Interventions: Drug: Clindamycin-gentamicin irrigation; Drug: Normal saline irrigation

• Registration Number: NCT02479971
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2014-01
• Status Verified: 2015-06
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Study First Submitted: 2015-06-17
• Study First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Study First Posted: 2015-06-24
• Last Update Posted: 2015-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clindamycin-gentamicin irrigation	Clindamycin-gentamicin irrigation	An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed.
Normal saline irrigation	Normal saline irrigation	An irrigation of the entire abdominal cavity with 500 ml normal saline will be performed.

Primary Outcome Measures

Name	Time	Method
Postoperative pain	24 hours after surgery	Postoperative pain will be evaluated by a Visual Analogic Scale 24 hours after surgery

Secondary Outcome Measures

Name	Time	Method
C reactive protein	24 hours after surgery	C reactive protein will be evaluated at a blood analoytics obtained 24 hours after surgery