Comparing Two Techniques of Haemostasis After Cervical Conization

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.

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Key information

Conditions

Cervical Intraepithelial Neoplasia Cervix Neoplasm Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Precancerous Conditions Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

19 year–68 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Hospital do Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Vaginal Packing

Procedure

This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique

Primary outcomes

Vaginal bleeding until 30 days after surgery

Time frame: Until 30 days after surgery

Bleeding was assessed by the need for reintervention.

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2014
Primary completion: 2015
Study completion: 2016
First posted: Sep 26, 2017
Registry last updated: Sep 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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