Comparing Two Techniques of Haemostasis After Cervical Conization

September 26, 2017 updated by: Ricardo dos Reis, Barretos Cancer Hospital

Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery

The LEEP conization is commonly used for cervical pathologies treatment. The techniques for hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after LEEP conization for management of cervical lesions.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer Hospital for patients with indication of LEEP conization. After local IRB approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using Chi-square test, Fisher exact test and t-test where appropriate.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Barretos, SP, Brazil, 14784-400
        • Hospital do Cancer de Barretos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Indication of cervical conization.

Exclusion Criteria:

  • We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Conization With Vaginal Packing
Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
Procedure: Vaginal Packing
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
ACTIVE_COMPARATOR: Conization Without Vaginal Packing
Haemostasis at the end of the procedure using only Monsel's solution.
Procedure: Vaginal Packing
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Vaginal bleeding until 30 days after surgery
Time Frame: Until 30 days after surgery
Bleeding was assessed by the need for reintervention.
Until 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barretos Cancer Hospital

Investigators

  • Principal Investigator: Ricardo D Reis, MD, Hospital do Cancer de Barretos

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2014

Primary Completion (ACTUAL)

June 30, 2015

Study Completion (ACTUAL)

January 30, 2016

Study Registration Dates

First Submitted

September 4, 2017

First Submitted That Met QC Criteria

September 25, 2017

First Posted (ACTUAL)

September 26, 2017

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2017

Last Update Submitted That Met QC Criteria

September 26, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 826/2014

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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