Pentraxin-3 in Hysterectomy Patients

April 28, 2020 updated by: Burak Sezgin, Muğla Sıtkı Koçman University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

40

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

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

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TLH+BSO
Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20
Diagnostic test: PTX-3
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.
TAH + BSO
Total Abdominal Hysterectomy + BSO N=20
Diagnostic test: PTX-3
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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Muğla Sıtkı Koçman University

Investigators

  • Principal Investigator: Burak SEZGİN, Dr, Mugla Sıtkı Kocman University Faculty of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2015

Primary Completion (Actual)

December 7, 2015

Study Completion (Actual)

December 7, 2015

Study Registration Dates

First Submitted

April 25, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19.03.15-58-56

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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