NCT03293628

Comparing Two Techniques of Haemostasis After Cervical Conization

Completed Phase 2 Last updated 28 September 2017

What this trial tests

Phase 2 trial testing Vaginal Packing in Cervical Intraepithelial Neoplasia in 100 participants. Completed in 30 January 2016.

Timeline

1 October 2014

Primary endpoint
30 June 2015

30 January 2016

Quick facts

Lead sponsor	Barretos Cancer Hospital
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	100
Start date	1 October 2014
Primary completion	30 June 2015
Estimated completion	30 January 2016
Sites	1 location across Brazil

Drugs / interventions tested

• Vaginal Packing

Conditions studied

• Cervical Intraepithelial Neoplasia — all drugs for Cervical Intraepithelial Neoplasia →
• Cervix Neoplasm — all drugs for Cervix Neoplasm →

Sponsor

Barretos Cancer Hospital

Who can join

Adults 19 to 68, female only, with Cervical Intraepithelial Neoplasia or Cervix Neoplasm. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.