Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

NCT03917134 | Unknown

• 1 other identifier: 815
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• Incidence of cellulitis and vaginal cuff abscess

  30 days

Secondary Outcomes (3)

• percentage of patients who will undergo laparoscopic hysterectomy have bacterial vaginosis at the time of the procedure.

  15 days

• need to perform additional procedures as part of the treatment in each of the groups.

  30 days

• percentage of patients who comply with the prescribed treatment completely.

  15 days

Study Arms (2)

cephalosporin + Metronidazole

EXPERIMENTAL

In this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. metronidazole vaginal ovules of 500mg twice a day for 5 days after surgery

Drug: cephalosporin + Metronidazole Vaginal

cephalosporin + placebo

PLACEBO COMPARATOR

In this arm, patients randomly selected, will receive cephalosporin in doses of 2 grams administered intravenously before surgery. placebo vaginal ovules twice a day for 5 days after surgery

Drug: cephalosporin + Placebos

Interventions

cephalosporin + Metronidazole Vaginal DRUG

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

cephalosporin + Metronidazole

cephalosporin + Placebos DRUG

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

cephalosporin + placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• CES University: lead
• Lafrancol S.A.: collaborator
• Prolab S.A: collaborator
• Clínica del prado: collaborator
• Clínica comfamiliar pereira: collaborator

Study Sites (2)

Clinica del prado

Medellín, Colombia

Location

Clínica comfamiliar pereira

Pereira, Colombia

Location

Related Publications (34)

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MeSH Terms

Conditions

Cellulitis; Vaginal Diseases; Abscess

Interventions

Cephalosporins

Condition Hierarchy (Ancestors)

Skin Diseases, Infectious; Infections; Suppuration; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• CLAUDIA LOPEZ, Gynecologist

  CES University - Clínica del prado

  PRINCIPAL INVESTIGATOR

Central Study Contacts

CLAUDIA LOPEZ, Gynecologist

CONTACT

3104365060; cclopez04@yahoo.com

VICTOR H VALENCIA

CONTACT

3128313718; vicval87@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: April 3, 2019
• First Posted: April 16, 2019
• Study Start: May 1, 2019
• Primary Completion: January 30, 2020
• Study Completion: January 30, 2020
• Last Updated: April 16, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will share

Locations

CO (2)