Comparing Two Techniques of Haemostasis After Cervical Co... | NCT03293628

Studies
Comparing Two Techniques of Haemostasis After Cervical Conization

NCT03293628

Sponsor

Barretos Cancer Hospital

Status

Completed

Last Update Posted

Sep 28, 2017Actual

Enrollment

100Actual

Phase

Phase 2

Conditions

Cervical Intraepithelial Neoplasia
Cervix Neoplasm

Interventions

Vaginal Packing

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 1, 2014Actual

Primary Completion Date

Jun 30, 2015Actual

Completion Date

Jan 30, 2016Actual

First Submitted Date

Sep 4, 2017

First Submission Date that Met QC Criteria

Sep 25, 2017

First Posted Date

Sep 26, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 26, 2017

Last Update Posted Date

Sep 28, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Vaginal bleeding until 30 days after surgery	Bleeding was assessed by the need for reintervention.	Until 30 days after surgery

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

68 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ricardo D Reis, MD	Hospital do Câncer de Barretos	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital do Câncer de Barretos		Barretos	São Paulo	14784-400	Brazil

Condition Browse Module

MeSH Terms

ID	Term
D002578	Uterine Cervical Dysplasia
D002583	Uterine Cervical Neoplasms

Ancestor Terms

ID	Term
D011230	Precancerous Conditions
D009369	Neoplasms
D002577	Uterine Cervical Diseases
D014591	Uterine Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

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.