Skip to content

Cold Knife Conization With and Without Lateral Hemostatic Sutures

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

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02184975
Enrollment
100
Registered
2014-07-09
Start date
2009-03-31
Completion date
2013-10-31
Last updated
2014-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical Intraepithelial Neoplasia, Cervix Neoplasms

Keywords

cold knife conization, lateral hemostatic sutures, cervix

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.

Interventions

PROCEDURECold 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.

PROCEDURECold 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.

Sponsors

Barretos Cancer Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
FEMALE
Age
15 Years to 80 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Intraoperatory vaginal bleedingIntraoperatoryThe intraoperatory bleeding will be measure by weigh the gauze in grams (g).

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026