Comparing Two Techniques of Haemostasis After Cervical Conization

Cervical Intraepithelial Neoplasia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03293628
• Other study ID #: 826/2014
• Status: Completed
• Phase: Phase 2
• First received: September 4, 2017
• Last updated: September 26, 2017
• Start date: October 1, 2014
• Est. completion date: January 30, 2016

Study information

• Verified date: September 2017
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 30, 2016
• Est. primary completion date: June 30, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 68 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma in Situ
• Cervical Intraepithelial Neoplasia
• Cervix Neoplasm
• Neoplasms
• Uterine Cervical Neoplasms

Intervention

Procedure:
• Vaginal Packing
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Locations

Country	Name	City	State
Brazil	Hospital do Câncer de Barretos	Barretos	SP

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal bleeding until 30 days after surgery	Bleeding was assessed by the need for reintervention.	Until 30 days after surgery