Brief Title
Comparing Two Techniques of Haemostasis After Cervical Conization
Official Title
Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery
Brief Summary
The LEEP conization is commonly used for cervical pathologies treatment. The techniques for
hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is
no consensus about the best technique and there is not much information that validates the
use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after
LEEP conization for management of cervical lesions.
Detailed Description
A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer
Hospital for patients with indication of LEEP conization. After local IRB approval, patients
were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with
vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative
and postoperative outcomes will be evaluated: operative time, intraoperative and
postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as
well as short-term outcome were recorded and compared using Chi-square test, Fisher exact
test and t-test where appropriate.
Study Phase
Phase 2
Study Type
Interventional
Primary Outcome
Vaginal bleeding until 30 days after surgery
Condition
Cervical Intraepithelial Neoplasia
Intervention
Vaginal Packing
Study Arms / Comparison Groups
Conization With Vaginal Packing
Description: Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
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
October 1, 2014
Completion Date
January 30, 2016
Primary Completion Date
June 30, 2015
Eligibility Criteria
Inclusion Criteria:
- Indication of cervical conization.
Exclusion Criteria:
- We excluded patients who were not treated by our department physicians or if the
patient did not return for follow-up.
Gender
Female
Ages
19 Years - 68 Years
Accepts Healthy Volunteers
No
Contacts
Ricardo D Reis, MD, ,
Location Countries
Brazil
Location Countries
Brazil
Administrative Informations
NCT ID
NCT03293628
Organization ID
826/2014
Responsible Party
Principal Investigator
Study Sponsor
Barretos Cancer Hospital
Study Sponsor
Ricardo D Reis, MD, Principal Investigator, Hospital do Câncer de Barretos
Verification Date
September 2017