NCT02184975

Cold Knife Conization With and Without Lateral Hemostatic Sutures

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Female
• Age: 15 Years – 80 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervix Neoplasms

Interventions

Type	Name	Description
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.
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.

Timeline

• Start date: 2009-03-01
• Primary completion: 2012-08-01
• Completion: 2013-10-01
• First posted: 2014-07-09
• Last updated: 2014-07-09

Locations

1 site across 1 country: Brazil