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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03917134
Other study ID # 815
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 1, 2019
Est. completion date January 30, 2020

Study information

Verified date April 2019
Source CES University
Contact CLAUDIA LOPEZ, Gynecologist
Phone 3104365060
Email cclopez04@yahoo.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Operative site infection remains the most common complication after performing a gynecological procedure, and has a great implication in the morbidity and mortality of patients. Gynecological procedures, including laparoscopic hysterectomy, represent a unique challenge due to the amount of microorganisms found at the skin level of the vagina or the endocervix.

However, there is no clear evidence that the complication decreases with the use of postoperative antibiotics.

With the completion of this study, a multicentre triple-blind controlled randomized controlled trial is intended to determine the behavior of the application of this intervention.

Patients who attend an outpatient clinic with benign pathology will be selected, in which indication of laparoscopic hysterectomy, consents are completed and research content is widely explained. Prior to surgery, the sample is taken for a gram of vaginal discharge and in the post-surgical phase delivery of the medication will be performed. Follow-up will be carried out by surgical control and by telephone.

The investigator intend to find that with the prophylaxis not only of presurgical cephalosporin, but with the formulation of metronidazole ovules in the postoperative, the incidence of laparoscopic post-hysterectomy vaginal abscess and cellulitis of cuff is reduced.


Description:

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Study Design


Related Conditions & MeSH terms


Intervention

Drug:
cephalosporin + Metronidazole Vaginal
administration of cephalosporin in doses of 2 grams administered intravenously before surgery and metronidazole vaginal ovules 500mg twice a day for 5 days after performing laparoscopic hysterectomy
cephalosporin + Placebos
administration of cephalosporin in doses of 2 grams administered intravenously before surgery and vaginal ovules of placebo twice a day for 5 days after performing laparoscopic hysterectomy

Locations

Country Name City State
Colombia Clinica del prado Medellín
Colombia Clínica comfamiliar pereira Pereira

Sponsors (5)

Lead Sponsor Collaborator
CES University Clínica comfamiliar pereira, Clínica del prado, Lafrancol S.A., Prolab S.A

Country where clinical trial is conducted

Colombia, 

References & Publications (33)

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Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of cellulitis and vaginal cuff abscess 30 days
Secondary percentage of patients who will undergo laparoscopic hysterectomy have bacterial vaginosis at the time of the procedure. 15 days
Secondary need to perform additional procedures as part of the treatment in each of the groups. 30 days
Secondary percentage of patients who comply with the prescribed treatment completely. 15 days
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