Cold Knife Conization With and Without Lateral Hemostatic Sutures

NCT ID: NCT02184975

Last Updated: 2014-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-03-31
• Study Completion Date: 2013-10-31

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervix Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Stitches

Cold Knife Conization with stitches

Group Type: EXPERIMENTAL

Cold Knife Conization with stitches

Intervention Type: PROCEDURE

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.

No stitches

Cold Knife Conization without stitches

Group Type: ACTIVE_COMPARATOR

Cold knife Conization without stitches

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Other Intervention Names

Cold Knife conization with sutures; Cervix hemostatic sutures; Cervix conization without hemostatic sutures; Cold knife conization without lateral sutures

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Barretos Cancer Hospital

OTHER

Sponsor Role: lead

Responsible Party

Ricardo dos Reis

Medical doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo D Reis, MD

Role: STUDY_CHAIR

Hospital de Clinicas de Porto Alegre-Brazil

Locations

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Countries

Brazil

References

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.

Reference Type: DERIVED

PMID: 25937157 (View on PubMed)

Other Identifiers

Conization1

Identifier Type: -

Identifier Source: org_study_id