Cold Knife Conization With and Without Lateral Hemostatic Sutures

Phase 2

Completed

• Conditions: Cervical Intraepithelial Neoplasia; Cervix Neoplasms
• Interventions: Procedure: Cold Knife Conization with stitches; Procedure: Cold knife Conization without stitches

• Registration Number: NCT02184975
• Lead Sponsor: Barretos Cancer Hospital

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.

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 Timeline

• Study Start: 2009-03
• Primary Completion: 2012-08
• Study Completion: 2013-10
• Study First Submitted: 2014-06-20
• Status Verified: 2014-07
• Study First Submitted QC: 2014-07-05
• Last Update Submitted: 2014-07-05
• Study First Posted: 2014-07-09
• Last Update Posted: 2014-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Stitches	Cold Knife Conization with stitches	Cold Knife Conization with stitches
No stitches	Cold knife Conization without stitches	Cold Knife Conization without stitches

Primary Outcome Measures

Name	Time	Method
Intraoperatory vaginal bleeding	Intraoperatory	The intraoperatory bleeding will be measure by weigh the gauze in grams (g).

Trial Locations

Locations (1)

Hospital de Clinicas de Porto Alegre; 🇧🇷 Porto Alegre, RS, Brazil