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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Normal saline irrigation

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

Group Type ACTIVE_COMPARATOR

Normal saline irrigation

Intervention Type DRUG

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

Clindamycin-gentamicin irrigation

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

Group Type EXPERIMENTAL

Clindamycin-gentamicin irrigation

Intervention Type DRUG

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

Interventions

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Clindamycin-gentamicin irrigation

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

Intervention Type DRUG

Normal saline irrigation

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

Intervention Type DRUG

Other Intervention Names

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Clindamycin-gentamicin solution Saline irrigation

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No