Comparing Two Techniques of Haemostasis After Cervical Conization

Barretos Cancer Hospital

Status and phase: Completed; Phase 2

Conditions: Cervix Neoplasm; Cervical Intraepithelial Neoplasia

Treatments: Procedure: Vaginal Packing

Study type: Interventional

Funder types: Other

Identifiers

NCT03293628

826/2014

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Female

Ages: 19 to 68 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

Conization With Vaginal Packing

Experimental group

Description:

Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.

Treatment:

Procedure: Vaginal Packing

Conization Without Vaginal Packing

Active Comparator group

Description:

Haemostasis at the end of the procedure using only Monsel's solution.

Treatment:

Procedure: Vaginal Packing