Cold Knife Conization With and Without Lateral Hemostatic Sutures

Study Overview
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Brief Summary
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The treatment of high grade Cervical Intraepithelial Neoplasia (CIN) 2, 3 is defined according to the colposcopic evaluation of the patient. In case colposcopy findings are satisfactory (visible squamocolumnar junction), both ablative and excisional methods are adequate. In the middle of the 20th century, lateral hemostatic sutures were added to the cold knife conization surgical technique to reduce blood loss. Some authors recommend that these branches should be ligated, but it remains unclear whether these sutures are actually effective in reducing bleeding.This study compared blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures.

Detailed Description
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This is a study that will evaluate two groups of patients undergoing cold-knife conization for cervical intraepithelial neoplasia high grade where 50% will undergo hemostatic sutures in the lateral cervical and 50% of patients will not be subjected to these sutures. The main objective of the study is to evaluate the amount of intraoperative bleeding.

Official Title
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Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures

Conditions
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Cervical Intraepithelial Neoplasia, Cervix Neoplasms

Intervention / Treatment
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* Procedure: Cold Knife Conization with stitches
* Procedure: Cold knife Conization without stitches


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: indication of cold knife conization Exclusion Criteria: conization using techniques other than the cold knife; previous cervical conization using any other technique; previous pelvic radiotherapy; pregnancy; and refusal to participate in the study

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stitches<br>Cold Knife Conization with stitches | Procedure: Cold Knife Conization with stitches<br>* In the research arm patients who underwent cold-knife conization of the cervix underwent hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. These sutures were held prior to the onset of cold conization of the cervix.<br>* Other names: Cervix hemostatic sutures;|
| Active Comparator: No stitches<br>Cold Knife Conization without stitches | Procedure: Cold knife Conization without stitches<br>* In the research arm patients who underwent cold-knife conization of the cervix have not undergone hemostatic sutures laterally to the cervix, at localization of 3 and 9 hours with 2-0 vicryl thread. After patient anesthesia and routine antisepsis was performed, cold knife conization of the cervix was performed.<br>* Other names: Cold knife conization without lateral sutures;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperatory vaginal bleeding | The intraoperatory bleeding will be measure by weigh the gauze in grams (g). | Intraoperatory | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cervix, cold knife conization, lateral hemostatic sutures