Pentraxin-3 in Hysterectomy Patients

Completed

• Conditions: Laparoscopic Hysterectomy; Abdominal Hysterectomy
• Interventions: Diagnostic Test: PTX-3

• Registration Number: NCT04366375
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

Study Timeline

• Study Start: 2015-01-13
• Primary Completion: 2015-12-07
• Study Completion: 2015-12-07
• Status Verified: 2020-04
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Last Update Submitted: 2020-04-28
• Last Update Posted: 2020-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TLH+BSO	PTX-3	Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20
TAH + BSO	PTX-3	Total Abdominal Hysterectomy + BSO N=20

Primary Outcome Measures

Name	Time	Method
Pentraxin-3 level	Before 24 hours preoperatively and upto 24 hours postoperatively	Pentraxin-3 ng/mL

Secondary Outcome Measures

Name	Time	Method
(NLR)	Up to 24 hours postoperative	neutrophile/lymphocyte ratio