Pentraxin-3 in Hysterectomy Patients

Laparoscopic Hysterectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366375
• Other study ID #: 19.03.15-58-56
• Status: Completed
• Start date: January 13, 2015
• Est. completion date: December 7, 2015

Study information

• Verified date: April 2020
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 7, 2015
• Est. primary completion date: December 7, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Abdominal Hysterectomy
• Laparoscopic Hysterectomy

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pentraxin-3 level	Pentraxin-3 ng/mL	Before 24 hours preoperatively and upto 24 hours postoperatively
Secondary	(NLR)	neutrophile/lymphocyte ratio	Up to 24 hours postoperative