Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

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.

Conditions

• Hysterectomy
• Cellulitis
• Vaginosis
• Abscess
• Cuff

Interventions

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

DRUG

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

Sponsors & Collaborators

• Lafrancol S.A.

  collaborator INDUSTRY

• Prolab S.A

  collaborator UNKNOWN

• Clínica del prado

  collaborator UNKNOWN

• Clínica comfamiliar pereira

  collaborator UNKNOWN

• CES University

  lead OTHER

Principal Investigators

• CLAUDIA LOPEZ, Gynecologist · CES University - Clínica del prado

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-05-01

Primary Completion

2020-01-30

Completion

2020-01-30

Countries

• Colombia

Study Locations