Comparing Two Techniques of Haemostasis After Cervical Conization

Phase 2

Completed

• Conditions: Cervix Neoplasm; Cervical Intraepithelial Neoplasia
• Interventions: Procedure: Vaginal Packing

• Registration Number: NCT03293628
• Lead Sponsor: Barretos Cancer Hospital

Brief 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.

Study Timeline

• Study Start: 2014-10-01
• Primary Completion: 2015-06-30
• Study Completion: 2016-01-30
• Status Verified: 2017-09
• Study First Submitted: 2017-09-04
• Study First Submitted QC: 2017-09-25
• Study First Posted: 2017-09-26
• Last Update Submitted: 2017-09-26
• Last Update Posted: 2017-09-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Indication of cervical conization.

Exclusion Criteria

• We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conization With Vaginal Packing	Vaginal Packing	Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
Conization Without Vaginal Packing	Vaginal Packing	Haemostasis at the end of the procedure using only Monsel's solution.

Primary Outcome Measures

Name	Time	Method
Vaginal bleeding until 30 days after surgery	Until 30 days after surgery	Bleeding was assessed by the need for reintervention.

Trial Locations

Locations (1)

Hospital do Câncer de Barretos; 🇧🇷 Barretos, SP, Brazil