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Comparing Two Techniques of Haemostasis After Cervical Conization

Primary Purpose

Cervical Intraepithelial Neoplasia, Cervix Neoplasm

Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Vaginal Packing
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring cervical intraepithelial neoplasia, haemostasis, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm

Eligibility Criteria

19 Years - 68 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital do Câncer de Barretos

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Conization With Vaginal Packing

Conization Without Vaginal Packing

Arm Description

Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.

Haemostasis at the end of the procedure using only Monsel's solution.

Outcomes

Primary Outcome Measures

Vaginal bleeding until 30 days after surgery
Bleeding was assessed by the need for reintervention.

Secondary Outcome Measures

Full Information

First Posted
September 4, 2017
Last Updated
September 26, 2017
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03293628
Brief Title
Comparing Two Techniques of Haemostasis After Cervical Conization
Official Title
Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
October 1, 2014 (Actual)
Primary Completion Date
June 30, 2015 (Actual)
Study Completion Date
January 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Cervix Neoplasm
Keywords
cervical intraepithelial neoplasia, haemostasis, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
Masking
Participant
Masking Description
The allocation of patients to one group or another was only known moments before the surgical procedure was started.
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conization With Vaginal Packing
Arm Type
Experimental
Arm Description
Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
Arm Title
Conization Without Vaginal Packing
Arm Type
Active Comparator
Arm Description
Haemostasis at the end of the procedure using only Monsel's solution.
Intervention Type
Procedure
Intervention Name(s)
Vaginal Packing
Intervention Description
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
Primary Outcome Measure Information:
Title
Vaginal bleeding until 30 days after surgery
Description
Bleeding was assessed by the need for reintervention.
Time Frame
Until 30 days after surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo D Reis, MD
Organizational Affiliation
Hospital do Câncer de Barretos
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital do Câncer de Barretos
City
Barretos
State/Province
SP
ZIP/Postal Code
14784-400
Country
Brazil

12. IPD Sharing Statement

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Comparing Two Techniques of Haemostasis After Cervical Conization

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