Cervical Intraepithelial NeoplasiaPhase 2NCT03293628
Comparing Two Techniques of Haemostasis After Cervical Conization
A Phase 2 study testing Vaginal Packing in people with Cervical Intraepithelial Neoplasia and Cervix Neoplasm, run by Barretos Cancer Hospital at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 68 years, women only
- Conditions the study is for
- Cervical Intraepithelial Neoplasia, Cervix Neoplasm
- What is being tested?
- Vaginal Packing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2014to 30 Jan 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 68 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication of cervical conization.
Who cannot join
- We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery
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.
Read the 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.
- Being tested
- Vaginal Packing
- Keywords
- cervical intraepithelial neoplasia, haemostasis, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm
- Medical subject headings
- Uterine Cervical Dysplasia, Uterine Cervical Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaginal PackingProcedure or surgery
This study will evaluate the role of vaginal packing after cervical conization as haemostasis technique
| Study group | Role | What they receive |
|---|---|---|
| Conization With Vaginal Packing | Experimental | Experimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution. Receives: Procedure: Vaginal Packing |
| Conization Without Vaginal Packing | Active comparator | Haemostasis at the end of the procedure using only Monsel's solution. Receives: Procedure: Vaginal Packing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal bleeding until 30 days after surgery
Bleeding was assessed by the need for reintervention.
Measured: Until 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2017
- Study start1 Oct 2014
- Primary completion30 Jun 2015
- Study completion30 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical Intraepithelial NeoplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barretos Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ricardo dos Reis, Barretos Cancer Hospital
- Investigators
- Ricardo D Reis, MD, Principal investigator, Hospital do Câncer de Barretos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03293628
- Sponsor's protocol ID
- 826/2014
- Status last verified
- Sep 2017
- First submitted
- 4 Sep 2017
- Last updated
- 28 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Two Techniques of Haemostasis After Cervical Conization With High Frequency Surgery
- ClinicalTrials.gov ID
- NCT03293628
- Acronym / sponsor ID
- 826/2014
- Keywords
- cervical intraepithelial neoplasia, haemostasis, vaginal pack, Loop electrical excision procedure, randomized clinical trials, uterine cervical neoplasm
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barretos Cancer HospitalUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 30 Jun 2015 (actual)
- Study completion
- 30 Jan 2016 (actual)
- First posted
- 26 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conization With Vaginal Packing | Experimental | Procedure: Vaginal PackingExperimental Arm. Haemostasis at the end of the procedure using vaginal packing and Monsel's solution. |
| Conization Without Vaginal Packing | Active comparator | Procedure: Vaginal PackingHaemostasis at the end of the procedure using only Monsel's solution. |
Who may qualify
- Ages
- 19 to 68 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Indication of cervical conization.
Key exclusion criteria (1 listed)
- We excluded patients who were not treated by our department physicians or if the patient did not return for follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vaginal PackingThis study will evaluate the role of vaginal packing after cervical conization as haemostasis technique | Procedure or surgery | Conization With Vaginal Packing, Conization Without Vaginal Packing |
Primary outcome
Vaginal bleeding until 30 days after surgery
Time frame: Until 30 days after surgery
Bleeding was assessed by the need for reintervention.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo D Reis, MD principal investigator
Hospital do Câncer de Barretos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vaginal Packing in people with Cervical Intraepithelial Neoplasia and Cervix Neoplasm, run by Barretos Cancer Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal bleeding until 30 days after surgery (time frame: Until 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.