Antibiotic Prophylaxis in Gynecologic Laparoscopy

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

NA

Total Enrollment

114 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-04-30

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.

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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.

Conditions

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Infection Secondary to Surgical Procedure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Placebo

Patients in this arm will receive intravenous sterile saline 30 minutes before the gynecologic laparoscopy.

Group Type PLACEBO_COMPARATOR

gynecologic laparoscopy

Intervention Type PROCEDURE

Gynecological laparoscopy without opening hollow viscera.

Placebo

Intervention Type DRUG

Intravenous administration of saline sterile solution

Cefazolin

Patients in this arm will receive intravenous cephazolin 1g, 30 minutes before the gynecologic laparoscopy.

Group Type ACTIVE_COMPARATOR

gynecologic laparoscopy

Intervention Type PROCEDURE

Gynecological laparoscopy without opening hollow viscera.

Cefazolin

Intervention Type DRUG

Intravenous administration of 1 g of cefazolin

Interventions

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gynecologic laparoscopy

Gynecological laparoscopy without opening hollow viscera.

Intervention Type PROCEDURE

Cefazolin

Intravenous administration of 1 g of cefazolin

Intervention Type DRUG

Placebo

Intravenous administration of saline sterile solution

Intervention Type DRUG

Other Intervention Names

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pelvic laparoscopy gynecologic laparoscopic surgery Cephazolin Cefazoline Cephazolin Sodium for Injection Kefzol placebo treatment

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No