Cold Knife Conization With and Without Lateral Hemostatic Sutures
Primary Purpose
Cervical Intraepithelial Neoplasia, Cervix Neoplasms
Status
Completed
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Cold Knife Conization with stitches
Cold knife Conization without stitches
Sponsored by
About this trial
This is an interventional treatment trial for Cervical Intraepithelial Neoplasia focused on measuring cold knife conization, lateral hemostatic sutures, cervix
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
Sites / Locations
- Hospital de Clinicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Stitches
No stitches
Arm Description
Cold Knife Conization with stitches
Cold Knife Conization without stitches
Outcomes
Primary Outcome Measures
Intraoperatory vaginal bleeding
The intraoperatory bleeding will be measure by weigh the gauze in grams (g).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02184975
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Intraepithelial Neoplasia, Cervix Neoplasms
Keywords
cold knife conization, lateral hemostatic sutures, cervix
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stitches
Arm Type
Experimental
Arm Description
Cold Knife Conization with stitches
Arm Title
No stitches
Arm Type
Active Comparator
Arm Description
Cold Knife Conization without stitches
Intervention Type
Procedure
Intervention Name(s)
Cold Knife Conization with stitches
Other Intervention Name(s)
Cold Knife conization with sutures, Cervix hemostatic sutures
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Cold knife Conization without stitches
Other Intervention Name(s)
Cervix conization without hemostatic sutures, Cold knife conization without lateral sutures
Intervention Description
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.
Primary Outcome Measure Information:
Title
Intraoperatory vaginal bleeding
Description
The intraoperatory bleeding will be measure by weigh the gauze in grams (g).
Time Frame
Intraoperatory
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo D Reis, MD
Organizational Affiliation
Hospital de Clinicas de Porto Alegre-Brazil
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital de Clinicas de Porto Alegre
City
Porto Alegre
State/Province
RS
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
25937157
Citation
Bueno LR, Binda M, Monego H, Scherer RL, Rolim KM, Bottini AL, Fregnani JH, dos Reis R. Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures. Int J Surg. 2015 Jun;18:224-9. doi: 10.1016/j.ijsu.2015.04.081. Epub 2015 Apr 30.
Results Reference
derived
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Cold Knife Conization With and Without Lateral Hemostatic Sutures
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