Cold Knife Conization With and Without Lateral Hemostatic Sutures

NCT02184975 | Completed Phase 2

• 1 other identifier: Conization1
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervix Neoplasms

Keywords

cold knife conization; lateral hemostatic sutures; cervix

Outcome Measures

Primary Outcomes (1)

• Intraoperatory vaginal bleeding

  The intraoperatory bleeding will be measure by weigh the gauze in grams (g).

  Intraoperatory

Study Arms (2)

Stitches

EXPERIMENTAL

Cold Knife Conization with stitches

Procedure: Cold Knife Conization with stitches

No stitches

ACTIVE COMPARATOR

Cold Knife Conization without stitches

Procedure: Cold knife Conization without stitches

Interventions

Cold Knife Conization with stitches 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.

Also known as: Cold Knife conization with sutures, Cervix hemostatic sutures

Stitches

Cold knife Conization without stitches 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.

Also known as: Cervix conization without hemostatic sutures, Cold knife conization without lateral sutures

No stitches

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• indication of cold knife conization

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Location

Related Publications (1)

• 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.

  PMID: 25937157 DERIVED

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Interventions

Conization; Sutures

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Investigative Techniques; Surgical Fixation Devices; Surgical Equipment; Equipment and Supplies

Study Officials

• Ricardo D Reis, MD

  Hospital de Clinicas de Porto Alegre-Brazil

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: June 20, 2014
• First Posted: July 9, 2014
• Study Start: March 1, 2009
• Primary Completion: August 1, 2012
• Study Completion: October 1, 2013
• Last Updated: July 9, 2014

Record last verified: 2014-07

Locations

BR (1)