Cold Knife Conization With and Without Lateral Hemostatic Sutures

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Cervix Neoplasms; Cervical Intraepithelial Neoplasia

Treatments: Procedure: Cold Knife Conization with stitches; Procedure: Cold knife Conization without stitches

Study type: Interventional

Funder types: Other

Identifiers

NCT02184975

Conization1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 15 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Stitches

Experimental group

Description:

Cold Knife Conization with stitches

Treatment:

Procedure: Cold Knife Conization with stitches

No stitches

Active Comparator group

Description:

Cold Knife Conization without stitches

Treatment:

Procedure: Cold knife Conization without stitches