Randomized clinical trial comparing cold knife conization of the cervix with and without lateral hemostatic sutures

Abstract

Objective: Compare blood loss during cold knife conization of the cervix with and without lateral hemostatic sutures in the cervical branches of the uterine arteries.

Design: Randomized clinical trial.

Setting: Hospital de Clínicas de Porto Alegre (HCPA).

Population: 102 patients that underwent cold knife conization.

Methods: Women that underwent cold knife conization of the cervix were randomized to undergo the procedure with or without lateral hemostatic sutures.

Primary outcome measure: blood loss measured in grams.

Secondary outcome measures: operative time and postoperative intervention. Only the participants were blinded to group assignment.

Results: From March 2009 to August 2012, patients were randomly assigned to one of the study groups. There were no differences in amount of blood loss between patients that underwent the procedure with and without sutures (p = 0.39). Operative time was shorter in the group without suture (p = 0.020). There were no differences in intervention due to bleeding (p = 0.20). Blood loss was greater among menstruating women than for menopausal women (p = 0.011). There were no differences in amount of blood lost between smoking and nonsmoking patients (p = 0.082).

Conclusions: Lateral hemostatic sutures do not affect the amount of intraoperative bleeding or the number of postoperative interventions. Their use is not necessary because they result in longer operative time, have a higher cost due to the use of suture material and pose the risk of ureter lesion in case the sutures are not placed at a lower position in the cervix. ClinicalTrials. gov identifier: NCT02184975.

Keywords: Cervical intraepithelial neoplasia; Cervix; Cold knife conization; Lateral hemostatic sutures; Surgical technique.