Antibiotic Prophylaxis in Gynecologic Laparoscopy

Study Overview
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Brief Summary
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Laparoscopy is a surgical procedure indicated for most gynecological pathologies and presents numerous advantages over laparotomy, among them lower rates of surgical site infection and less comorbidity feverish. Despite this, the use of antibiotic prophylaxis is widely accepted and performed by most gynecologists. However, there isn't literature evidence to support the routine use of antibiotics in the prophylaxis of wound infection on laparoscopic pelvic surgery .Therefore, this study will evaluate the need for the use of antibiotic prophylaxis in gynecological laparoscopies not including opening hollow viscera.

Detailed Description
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It is a clinical, prospective, double-blind, randomized study. 114 women with gynecologic disease, in which there is indication of laparoscopic surgical approach, will be consecutively select. These women will be allocated in two arms, control and study, where control group will use placebo and study will receive intravenous cephazolin. These patients will be followed for 30 days according to Centers for Disease Control and Prevention criteria.

Official Title
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Antibiotic Prophylaxis in Gynecologic Laparoscopy

Conditions
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Infection Secondary to Surgical Procedure

Intervention / Treatment
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* Procedure: gynecologic laparoscopy
* Drug: Cefazolin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients with gynecologic disease, undergoing gynecologic laparoscopy without opening hollow viscera. Exclusion Criteria: body mass index over 30 Kg/m2 smoking diabetes type I or II with glycated hemoglobin exceeding 6.5% patients who are at surgical risk classification of the American Society of Anesthesiologists(ASA) as ASA III or higher refusal to participate postoperative antibiotic therapy for another indication clinical complication

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy. | Procedure: gynecologic laparoscopy<br>* Gynecological laparoscopy without opening hollow viscera.<br>* Other names: gynecologic laparoscopic surgery;Drug: Placebo<br>* Intravenous administration of saline sterile solution<br>* Other names: placebo treatment;|
| Active Comparator: Cefazolin<br>Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy. | Procedure: gynecologic laparoscopy<br>* Gynecological laparoscopy without opening hollow viscera.<br>* Other names: gynecologic laparoscopic surgery;Drug: Cefazolin<br>* Intravenous administration of 1 g of cefazolin<br>* Other names: Kefzol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical site infection | Patients are followed weekly by a masked surgeon in regard to surgical site infecton (SSI), until the 30th postoperative day. Centers for Disease Control and Prevention's (CDC) criteria and classification were adopted. | 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopy, surgical wound infection, antibiotic prophylaxis, gynecologic surgical procedures