A Phase 2 interventional study of Vaginal Packing in Cervical Intraepithelial Neoplasia and Cervix Neoplasm, sponsored by Barretos Cancer Hospital. Completed at 1 site in Brazil. Open to female participants aged 19 Years to 68 Years. Per ClinicalTrials.gov, last updated 2017-09-28.
Sponsored by Barretos Cancer Hospital · Phase 2, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
Procedure: Vaginal Packing
Haemostasis at the end of the procedure using only Monsel's solution.
Procedure: Vaginal Packing
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
Vaginal bleeding until 30 days after surgery
Bleeding was assessed by the need for reintervention.
Time frame: Until 30 days after surgery
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Barretos Cancer Hospital