Hysterectomy Clinical Trial
Official title:
Efficacy of the Use of Metronidazole After Laparoscopic Hysterectomy for the Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess. Multicentric Triple-blind Randomized Controlled Trial
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.
Status | Not yet recruiting |
Enrollment | 600 |
Est. completion date | January 30, 2020 |
Est. primary completion date | January 30, 2020 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility |
Inclusion Criteria: - Patients between 18 and 55 years old scheduled for laparoscopic hysterectomy for benign pathology in the two centers linked to the study (Clínica del Prado and Pereira community clinic), who have been informed of their participation in the study and who have signed informed consent. - Patients who are able to communicate by telephone and answer questions Exclusion Criteria: - Patients who are participating in another study of antibiotic treatment. - Patients who have a known allergy to imidazole medications. - Patients with current diagnosis of bacterial vaginosis. - Patients with current treatment or 30 days prior to surgery for bacterial vaginosis or antibiotic treatment for another pathology. - Patients who do not reside in Medellín or in its nearby municipalities and can not attend the scheduled evaluation. |
Country | Name | City | State |
---|---|---|---|
Colombia | Clinica del prado | Medellín | |
Colombia | Clínica comfamiliar pereira | Pereira |
Lead Sponsor | Collaborator |
---|---|
CES University | Clínica comfamiliar pereira, Clínica del prado, Lafrancol S.A., Prolab S.A |
Colombia,
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* Note: There are 33 references in all — Click here to view all references
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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