Cold Knife Conization With and Without Lateral Hemostatic Sutures

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02184975
• Other study ID #: Conization1
• Status: Completed
• Phase: Phase 2
• First received: June 20, 2014
• Last updated: July 5, 2014
• Start date: March 2009
• Est. completion date: October 2013

Study information

• Verified date: July 2014
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervix Neoplasms
• Uterine Cervical Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Hospital de Clinicas de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperatory vaginal bleeding	The intraoperatory bleeding will be measure by weigh the gauze in grams (g).	Intraoperatory	Yes