Comparing Two Techniques of Haemostasis After Cervical Conization

Last updated: September 26, 2017
Sponsor: Barretos Cancer Hospital
Overall Status: Completed

Phase

2

Condition

Cervical Intraepithelial Neoplasia

Precancerous Condition

Uterine Disorders

Treatment

N/A

Clinical Study ID

NCT03293628
826/2014
  • Ages 19-68
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Indication of cervical conization.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 100
Study Start date:
October 01, 2014
Estimated Completion Date:
January 30, 2016

Study 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.

Connect with a study center

  • Hospital do Câncer de Barretos

    Barretos, SP 14784-400
    Brazil

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.