Pentraxin-3 in Hysterectomy Patients | NCT04366375

Studies
Pentraxin-3 in Hysterectomy Patients

NCT04366375

Sponsor

Muğla Sıtkı Koçman University

Status

Completed

Last Update Posted

Apr 30, 2020Actual

Enrollment

40Actual

Phase

Not provided

Conditions

Laparoscopic Hysterectomy
Abdominal Hysterectomy

Interventions

PTX-3

Countries

Not provided

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

Apr 2020

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

Jan 13, 2015Actual

Primary Completion Date

Dec 7, 2015Actual

Completion Date

Dec 7, 2015Actual

First Submitted Date

Apr 25, 2020

First Submission Date that Met QC Criteria

Apr 27, 2020

First Posted Date

Apr 28, 2020Actual

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

Apr 28, 2020

Last Update Posted Date

Apr 30, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman UniversityPrincipal Investigator

Lead Sponsor

Muğla Sıtkı Koçman UniversityOTHER

Collaborators

Not provided

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

Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy

Detailed Description

Acute trauma and major surgeries activate a series of cascades to evoke systemic inflammatory response. The magnitude of the resulting inflammatory response is proportional to the severity of the tissue trauma. Abdominal or laparoscopic technique is widely used for the purpose of hysterectomy surgery. It is crucial for many aspects to compare these two techniques of hysterectomy in terms of the surgery-induced trauma.

In this study, the severity of the inflammatory response resulting from the tissue trauma due to the techniques of TLH+BSO and TAH+BSO applied in our department were compared based on the PTX-3 molecule.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
TLH+BSO		Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20	Diagnostic Test: PTX-3
TAH + BSO		Total Abdominal Hysterectomy + BSO N=20	Diagnostic Test: PTX-3

Interventions

Name	Type	Description	Arm Group Labels	Other Names
PTX-3	Diagnostic Test	Pentraxin-3 ng/mL PTX-3 levels were measured using human PTX3 ELISA Kit 96 Tests/Box (Cat. No: CK-E90303) (Hangzhou Eastbiopharm Co.,Ltd., PRC) read by a ELISA device matching with the kit. For the purpose of measurement, microplate washer RT 2600 device and Rayto microplate reader RT 2100C device were used.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Pentraxin-3 level	Pentraxin-3 ng/mL	Before 24 hours preoperatively and upto 24 hours postoperatively

Secondary Outcomes

Measure	Description	Time Frame
(NLR)	neutrophile/lymphocyte ratio	Up to 24 hours postoperative

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

·TLH+BSO patients and TAH+BSO patients

Exclusion Criteria:

History of a chronic disease (coronary artery disease, diabetes mellitus, hypertension, coronary liver failures, chronic kidney disease, chronic respiratory diseases, connective tissue disorders) which may affect levels of PTX-3 and other inflammatory markers.
Prior surgery due to malignancy.
History of an intra-abdominal surgery, except for cesarean section.
History of any disease which may lead to intra-abdominal adhesions (endometriosis, past pelvic infection).

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

TLH+BSO and TAH+BSO applied patients

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

A total of 40 patients, composed of 20 TLH+BSO patients and 20 TAH+BSO patients were included into the study.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Burak SEZGİN, Dr	Mugla Sıtkı Kocman University Faculty of Medicine	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

undecided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided