Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy
Status:
Unknown status
Trial end date:
2020-01-30
Target enrollment:
Participant gender:
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.
Phase:
N/A
Details
Lead Sponsor:
CES University
Collaborators:
Clínica comfamiliar pereira Clínica del prado Lafrancol S.A. Prolab S.A