NCT03293628

Comparing Two Techniques of Haemostasis After Cervical Conization

Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Barretos Cancer Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 68 Years
• Healthy volunteers: Not accepted

Summary

The LEEP conization is commonly used for cervical pathologies treatment. The techniques for hemostasis usually used are: cautery, Monsel's solution and vaginal pack. Actually, there is no consensus about the best technique and there is not much information that validates the use of some of that. To compare the use or not of vaginal pack as methods of hemostasis after LEEP conization for management of cervical lesions.

Detailed description

A randomized clinical trial was conducted at Gynecology Oncology Department/Barretos Cancer Hospital for patients with indication of LEEP conization. After local IRB approval, patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2). The Monsel's solution was used in all patients. Intraoperative and postoperative outcomes will be evaluated: operative time, intraoperative and postoperative bleeding, hormonal status, age, parity and cone specimens' characteristics as well as short-term outcome were recorded and compared using Chi-square test, Fisher exact test and t-test where appropriate.

Conditions

• Cervical Intraepithelial Neoplasia
• Cervix Neoplasm

Interventions

Type	Name	Description
PROCEDURE	Vaginal Packing	This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Timeline

• Start date: 2014-10-01
• Primary completion: 2015-06-30
• Completion: 2016-01-30
• First posted: 2017-09-26
• Last updated: 2017-09-28

Locations

1 site across 1 country: Brazil