Cervical Intraepithelial Neoplasia, Cervix Neoplasm
Conditions
Keywords
cervical intraepithelial neoplasia, haemostasis, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm
Brief 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.
Detailed 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.
Interventions
PROCEDUREVaginal Packing
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
Sponsors
Barretos Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
The allocation of patients to one group or another was only known moments before the surgical procedure was started.
Intervention model description
Patients were allocated in two arms (50 patients each): without vaginal pack (group 1 - GP1) and with vaginal pack (group 2 - GP2).Randomization was generated through a computer program creating a random entry list in the study, separating in group 1 (local application of Monsel's solution without intra-vaginal gauze buffer) and group 2 (application of Monsel's solution with intra-vaginal gauze). In this way, all patients had an equal chance of being included in both groups.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 68 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaginal bleeding until 30 days after surgery | Until 30 days after surgery | Bleeding was assessed by the need for reintervention. |
Countries
Brazil
Outcome results
None listed