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Prevention of Vaginal Cellulitis or Vaginal Cuff Abscess After Laparoscopic Hysterectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03917134
Recruitment Status : Unknown
Verified April 2019 by Claudia López, CES University.
Recruitment status was:  Not yet recruiting
First Posted : April 16, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborators:
Lafrancol S.A.
Prolab S.A
Clínica del prado
Clínica comfamiliar pereira
Information provided by (Responsible Party):
Claudia López, CES University

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.


Condition or disease Intervention/treatment Phase
Hysterectomy Cellulitis Vaginosis Abscess Cuff Drug: cephalosporin + Metronidazole Vaginal Drug: cephalosporin + Placebos Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Estimated Study Start Date : May 1, 2019
Estimated Primary Completion Date : January 30, 2020
Estimated Study Completion Date : January 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: cephalosporin + Metronidazole
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
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

Placebo Comparator: cephalosporin + placebo
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
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




Primary Outcome Measures :
  1. Incidence of cellulitis and vaginal cuff abscess [ Time Frame: 30 days ]

Secondary Outcome Measures :
  1. percentage of patients who will undergo laparoscopic hysterectomy have bacterial vaginosis at the time of the procedure. [ Time Frame: 15 days ]
  2. need to perform additional procedures as part of the treatment in each of the groups. [ Time Frame: 30 days ]
  3. percentage of patients who comply with the prescribed treatment completely. [ Time Frame: 15 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03917134


Contacts
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Contact: CLAUDIA LOPEZ, Gynecologist 3104365060 cclopez04@yahoo.com
Contact: VICTOR H VALENCIA 3128313718 vicval87@hotmail.com

Locations
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Colombia
Clinica del prado
Medellín, Colombia
Contact    5745765700      
Principal Investigator: CLAUDIA LOPEZ, Gynecologist         
Clínica comfamiliar pereira
Pereira, Colombia
Contact    5763135700      
Principal Investigator: JUAN D VILLEGAS, Gynecologist         
Sponsors and Collaborators
CES University
Lafrancol S.A.
Prolab S.A
Clínica del prado
Clínica comfamiliar pereira
Investigators
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Principal Investigator: CLAUDIA LOPEZ, Gynecologist CES University - Clínica del prado
Publications of Results:

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Responsible Party: Claudia López, Principal investigator, CES University
ClinicalTrials.gov Identifier: NCT03917134    
Other Study ID Numbers: 815
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Abscess
Cellulitis
Suppuration
Infection
Inflammation
Pathologic Processes
Skin Diseases, Infectious
Connective Tissue Diseases
Metronidazole
Cephalosporins
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents