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Cold Knife Conization With and Without Lateral Hemostatic Sutures

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ClinicalTrials.gov Identifier: NCT02184975
Recruitment Status : Completed
First Posted : July 9, 2014
Last Update Posted : July 9, 2014
Sponsor:
Information provided by (Responsible Party):
Ricardo dos Reis, 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.

Condition or disease Intervention/treatment Phase
Cervical Intraepithelial Neoplasia Cervix Neoplasms Procedure: Cold Knife Conization with stitches Procedure: Cold knife Conization without stitches Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Randomized Clinical Trial Comparing Cold Knife Conization of the Cervix With and Without Lateral Hemostatic Sutures
Study Start Date : March 2009
Actual Primary Completion Date : August 2012
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Stitches
Cold Knife Conization with stitches
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.
Other Names:
  • Cold Knife conization with sutures
  • Cervix hemostatic sutures

Active Comparator: No stitches
Cold Knife Conization without stitches
Procedure: 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.
Other Names:
  • Cervix conization without hemostatic sutures
  • Cold knife conization without lateral sutures




Primary Outcome Measures :
  1. Intraoperatory vaginal bleeding [ Time Frame: Intraoperatory ]
    The intraoperatory bleeding will be measure by weigh the gauze in grams (g).



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Ages Eligible for Study:   15 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02184975


Locations
Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, Brazil
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Study Chair: Ricardo D Reis, MD Hospital de Clinicas de Porto Alegre-Brazil

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ricardo dos Reis, Medical doctor, Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02184975     History of Changes
Other Study ID Numbers: Conization1
First Posted: July 9, 2014    Key Record Dates
Last Update Posted: July 9, 2014
Last Verified: July 2014

Keywords provided by Ricardo dos Reis, Barretos Cancer Hospital:
cold knife conization
lateral hemostatic sutures
cervix

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Uterine Cervical Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Carcinoma in Situ
Carcinoma
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Hemostatics
Coagulants