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.
The development of the project will be carried out in the facilities of the Prado clinic in
the city of Medellín and the Comfamily Clinic in the city of Pereira. Initially to the
participants who attend by external consultation for assessment by the laparoscopic
gynecology group that are candidates to perform a laparoscopic hysterectomy, they will be
given general information about the research in development and its possible participation.
Later on the day of surgery in the preparation room and before receiving any medication, The
assigned investigator as assistant to the surgery will explain in detail the protocol of the
investigation, the commitments acquired by the participant and the possibilities of
withdrawal of the same, you will obtain the signature and trace of the informed consent. With
the aim of not delaying the 7 am surgical program, a weekly resident will be assigned to
inform and fill out the forms of the first patients scheduled for hysterectomy.
Advance by means of a table of random numbers generated in EPIDAT and that is hidden for the
researcher. Participants will be assigned to one of the 2 groups, the intervention group will
receive the treatment scheme with metronidazole 500mg ovules every 12 hours for 5 days and
the control group will receive a placebo.
After this in the surgery room and with the participants under general anesthesia, the sample
will be taken for gram of vaginal discharge, previous marking of the plate, with the initials
of names and surnames and the patient's identification number, With the use of a speculum and
applicator the sample will be taken in the sack bottoms or vaginal walls, which will be sent
to the Prolab laboratory in the city of Medellín and the laboratory of the Comfamily clinic
in the city of Pereira. for its processing, standardization will be made prior to reading it
with the staff of both laboratories.
For the diagnosis of bacterial vaginosis, the Nugent criteria will be used. In this method,
the morphotypes corresponding to large Gram-positive bacilli, small Gram-negative bacilli and
curved variable Gram bacilli are quantified. And a value is assigned according to the
findings. The interpretation of the results is numerical based on the score obtained by
adding the crosses of the morphotypes of the bacteria present in the vaginal discharge: 7 or
more points are diagnostic of bacterial vaginosis, from 4 to 6 points is considered
intermediate and from 0 to 3 is considered normal.
At the end of the surgical procedure, the investigator will complete the completion of Annex
1, will go to the pharmaceutical service where he will request the corresponding product to
the patient. The pharmacy staff will verify the assigned number in the randomization table
and deliver the medication and the resident will take it to the recovery room with its
respective formula.
The assigned investigator will conduct a telephone interview 7 days after the procedure to
assess the post-surgical evolution, will be questioned about the presence of symptoms that
may be related to an infectious process. Between 10-15 days of the surgical procedure, the
gynecologist will perform the post-surgical review in an outpatient clinic to assess the
evolution of the patient and re-evaluate the result of the pathology. The Gram result of
vaginal discharge, the pathology and the evolution note made by the surgeon will be reviewed
with the aim of detecting any diagnosed complication. Finally, 30 days after the procedure,
the last telephone follow-up will be performed to detect the presence of any infection. of
the operative site.
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