---
title: Comparing Two Techniques of Haemostasis After Cervical Conization
nct_id: NCT03293628
overall_status: COMPLETED
phase: PHASE2
sponsor: Barretos Cancer Hospital
study_type: INTERVENTIONAL
primary_condition: Cervical Intraepithelial Neoplasia
countries: Brazil
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03293628.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03293628"
ct_last_update_post_date: 2017-09-28
last_seen_at: "2026-05-12T06:31:27.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Comparing Two Techniques of Haemostasis After Cervical Conization

**Official Title:** Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery

**NCT ID:** [NCT03293628](https://clinicaltrials.gov/study/NCT03293628)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 100
- **Lead Sponsor:** Barretos Cancer Hospital
- **Conditions:** Cervical Intraepithelial Neoplasia, Cervix Neoplasm
- **Start Date:** 2014-10-01
- **Completion Date:** 2016-01-30
- **CT.gov Last Update:** 2017-09-28

## 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.

## Eligibility

- **Minimum age:** 19 Years
- **Maximum age:** 68 Years
- **Sex:** FEMALE
- **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.
```

## Arms

- **Conization With Vaginal Packing** (EXPERIMENTAL) — Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution.
- **Conization Without Vaginal Packing** (ACTIVE_COMPARATOR) — Haemostasis at the end of the procedure using only Monsel's solution.

## Interventions

- **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.

## Locations (1)

- Hospital do Câncer de Barretos, Barretos, São Paulo, Brazil

## Recent Field Changes (last 30 days)

- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.hospital do câncer de barretos|barretos|são paulo|brazil` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03293628.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03293628*  
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