- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04366375
Pentraxin-3 in Hysterectomy Patients
Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy
Study Overview
Status
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
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
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
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
TLH+BSO
Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20
|
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
|
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
Sponsor
Investigators
- Principal Investigator: Burak SEZGİN, Dr, Mugla Sıtkı Kocman University Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 19.03.15-58-56
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Abdominal Hysterectomy
-
Kocaeli UniversityCompletedAbdominal HysterectomyTurkey
-
Zeynep Kamil Maternity and Pediatric Research and...UnknownTOTAL ABDOMINAL HYSTERECTOMYTurkey
-
Singapore General HospitalUnknownAbdominal Hysterectomy (& Wertheim)
-
Baskent UniversityCompletedAbdominal Hysterectomy (& Wertheim)Turkey
-
Turku University HospitalCompletedAbdominal Hysterectomy (& Wertheim)Finland
-
KK Women's and Children's HospitalWithdrawnTotal Abdominal Hysterectomy
-
Hvidovre University HospitalUnknown
-
Southern HealthGyrus ACMIUnknownTotal Abdominal HysterectomyAustralia
-
University of OttawaCompletedElective Total or Subtotal Abdominal HysterectomyCanada
-
Aswan University HospitalCompletedAbdominal HysterectomyEgypt
Clinical Trials on PTX-3
-
Cook Group IncorporatedCompletedRenal Artery StenosisUnited Kingdom, Germany, Czechia, France
-
Cook Group IncorporatedCompleted
-
Palvella Therapeutics, Inc.Active, not recruitingPachyonychia CongenitaUnited States
-
Proviva Therapeutics, Inc.Not yet recruitingSolid Tumor | Metastatic Cancer | Advanced Cancer
-
Prescient Therapeutics, Ltd.RecruitingAdvanced Cancer | PTCLAustralia
-
Palvella Therapeutics, Inc.UnknownPachyonychia CongenitaUnited States
-
The Second Hospital of Anhui Medical UniversityUnknownSecondary HyperparathyroidismChina
-
Flanders Medical Research ProgramUnknown
-
Yonsei UniversityUnknownFemoropopliteal Artery DiseaseKorea, Republic of
-
AkesoRecruitingGastric Adenocarcinoma and Gastroesophageal Junction AdenocarcinomaChina