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Comparing Two Techniques of Haemostasis After Cervical Conization

NCT ID: NCT03293628

Last Updated: 2017-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-01

Study Completion Date

2016-01-30

Brief Summary

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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

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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.

Conditions

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Cervical Intraepithelial Neoplasia Cervix Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
The allocation of patients to one group or another was only known moments before the surgical procedure was started.

Study Groups

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Conization With Vaginal Packing

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

Group Type EXPERIMENTAL

Vaginal Packing

Intervention Type PROCEDURE

This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Conization Without Vaginal Packing

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

Group Type ACTIVE_COMPARATOR

Vaginal Packing

Intervention Type PROCEDURE

This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Interventions

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Vaginal Packing

This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

68 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Barretos Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ricardo dos Reis

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ricardo D Reis, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital do Câncer de Barretos

Locations

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Hospital do Câncer de Barretos

Barretos, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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826/2014

Identifier Type: -

Identifier Source: org_study_id