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

Hospital General Universitario Elche

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Clindamycin-gentamicin irrigation; Drug: Normal saline irrigation

Study type: Interventional

Funder types: Other

Identifiers

NCT02479971

HGUE 2015-5

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Normal saline irrigation

Active Comparator group

Description:

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

Treatment:

Drug: Normal saline irrigation

Clindamycin-gentamicin irrigation

Experimental group

Description:

An irrigation of the entire abdominal cavity with 500 ml gentamicin and clyndamycin solution will be performed.

Treatment:

Drug: Clindamycin-gentamicin irrigation