Cold Knife Conization With and Without Lateral Hemostatic Sutures

Sponsor

Barretos Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02184975

Collaborator

(none)

100

Enrollment

Location

Arms

Duration (Months)

1.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia Cervix Neoplasms	Procedure: Cold Knife Conization with stitches Procedure: Cold knife Conization without stitches	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Mar 1, 2009

Actual Primary Completion Date :

Aug 1, 2012

Actual Study Completion Date :

Oct 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stitches Cold Knife Conization with stitches	Procedure: Cold Knife Conization with stitches 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. Other Names: Cold Knife conization with sutures Cervix hemostatic sutures
Active Comparator: No stitches Cold Knife Conization without stitches	Procedure: Cold knife Conization without stitches 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. Other Names: Cervix conization without hemostatic sutures Cold knife conization without lateral sutures

Arm

Intervention/Treatment

Experimental: Stitches

Cold Knife Conization with stitches

Procedure: Cold Knife Conization with stitches

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.

Other Names:

Cold Knife conization with sutures

Cervix hemostatic sutures

Active Comparator: No stitches

Cold Knife Conization without stitches

Procedure: Cold knife Conization without stitches

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.

Other Names:

Cervix conization without hemostatic sutures

Cold knife conization without lateral sutures

Outcome Measures

Primary Outcome Measures

Intraoperatory vaginal bleeding [Intraoperatory]
The intraoperatory bleeding will be measure by weigh the gauze in grams (g).

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS	Brazil

Sponsors and Collaborators

Barretos Cancer Hospital

Investigators

Study Chair: Ricardo D Reis, MD, Hospital de Clinicas de Porto Alegre-Brazil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ricardo dos Reis, Medical doctor, Barretos Cancer Hospital

ClinicalTrials.gov Identifier:

NCT02184975

Other Study ID Numbers:

Conization1

First Posted:

Jul 9, 2014

Last Update Posted:

Jul 9, 2014

Last Verified:

Jul 1, 2014

Keywords provided by Ricardo dos Reis, Medical doctor, Barretos Cancer Hospital

cold knife conization

lateral hemostatic sutures

cervix

Additional relevant MeSH terms:

Cervical Intraepithelial Neoplasia

Uterine Cervical Neoplasms

Hemostatics

Study Results

No Results Posted as of Jul 9, 2014