Comparing Two Techniques of Haemostasis After Cervical Conization

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cervix Neoplasm, Cervical Intraepithelial Neoplasia

Intervention / Treatment
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* Procedure: Vaginal Packing


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conization With Vaginal Packing<br>Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution. | Procedure: Vaginal Packing<br>* This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique<br>|
| Active Comparator: Conization Without Vaginal Packing<br>Haemostasis at the end of the procedure using only Monsel's solution. | Procedure: Vaginal Packing<br>* This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal bleeding until 30 days after surgery | Bleeding was assessed by the need for reintervention. | Until 30 days after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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haemostasis, cervical intraepithelial neoplasia, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm