Brief Title
Cold Knife Conization With and Without Lateral Hemostatic Sutures
Official Title
Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures
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 Phase
Phase 2
Study Type
Interventional
Primary Outcome
Intraoperatory vaginal bleeding
Condition
Cervical Intraepithelial Neoplasia
Intervention
Cold Knife Conization with stitches
Study Arms / Comparison Groups
Stitches
Description: Cold Knife Conization with stitches
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
100
Start Date
March 2009
Completion Date
October 2013
Primary Completion Date
August 2012
Eligibility Criteria
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
Gender
Female
Ages
15 Years - 80 Years
Accepts Healthy Volunteers
No
Contacts
Ricardo D Reis, MD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT02184975
Organization ID
Conization1
Responsible Party
Principal Investigator
Study Sponsor
Barretos Cancer Hospital
Study Sponsor
Ricardo D Reis, MD, Study Chair, Hospital de Clinicas de Porto Alegre-Brazil
Verification Date
July 2014