Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Intraepithelial Neoplasia | Cervical Intraepithelial Neoplasia | ONTOLOGY_EXACT | 0.98 |
| Cervix Neoplasms | Cervical Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cold knife Conization without stitches | Procedure | — | UNRESOLVED |
| Cold Knife Conization with stitches | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Stitches
- description
- Cold Knife Conization with stitches
- interventionNames
- Procedure: Cold Knife Conization with stitches
- type
- ACTIVE_COMPARATOR
- label
- No stitches
- description
- Cold Knife Conization without stitches
- interventionNames
- Procedure: Cold knife Conization without stitches
Primary outcomes (1)
- measure
- Intraoperatory vaginal bleeding
- timeFrame
- Intraoperatory
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 15 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBueno 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