Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

• Status: Unknown status
• Trial end date: 2020-01-30
• Target enrollment: 0
• Participant gender: Female

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: CES University
• Collaborators: Clínica comfamiliar pereira; Clínica del prado; Lafrancol S.A.; Prolab S.A
• Treatments: Cephalosporins; Metronidazole

Criteria

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.