Comparing Two Techniques of Haemostasis After Cervical Conization

NCT03293628 | Completed Phase 2

• 1 other identifier: 826/2014
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Intraepithelial Neoplasia; Cervix Neoplasm

Keywords

cervical intraepithelial neoplasia; haemostasis; vaginal pack; Loop electrical excision procedure; randomized clinical trials; uterine cervical neoplasm

Outcome Measures

Primary Outcomes (1)

• Vaginal bleeding until 30 days after surgery

  Bleeding was assessed by the need for reintervention.

  Until 30 days after surgery

Study Arms (2)

Conization With Vaginal Packing

EXPERIMENTAL

Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.

Procedure: Vaginal Packing

Conization Without Vaginal Packing

ACTIVE COMPARATOR

Haemostasis at the end of the procedure using only Monsel's solution.

Procedure: Vaginal Packing

Interventions

Vaginal Packing PROCEDURE

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

Conization With Vaginal Packing; Conization Without Vaginal Packing

Eligibility Criteria

• Age: 19 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Indication of cervical conization.

You may not qualify if:

• We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Hospital do Câncer de Barretos

Barretos, São Paulo, 14784-400, Brazil

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site

Study Officials

• Ricardo D Reis, MD

  Hospital do Câncer de Barretos

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The allocation of patients to one group or another was only known moments before the surgical procedure was started.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Model Details: 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.

Study Record Dates

• First Submitted: September 4, 2017
• First Posted: September 26, 2017
• Study Start: October 1, 2014
• Primary Completion: June 30, 2015
• Study Completion: January 30, 2016
• Last Updated: September 28, 2017

Record last verified: 2017-09

Locations

BR (1)