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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05003297
Other study ID # GaziosmanpasaTREHd
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2014
Est. completion date December 30, 2018

Study information

Verified date July 2021
Source Gaziosmanpasa Research and Education Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Due to short hospital stay, rapid return to work, less pain, and good cosmetic results, laparoscopic hysterectomy ( LH) has substantially increased the era of hysterectomy procedures especially for the last two decades. The main reason for this is probably that LH leads to fewer inflammatory responses when compared to open abdominal hysterectomy. Although the inflammatory response is supposed to be lower with total laparoscopic hysteroscopy (TLH), unpredictable inflammatory response as a result of the operation has been still unenlightened and it can be associated with hospital stay.


Description:

IInflammatory response after surgery is an ordinary outcome which ends up with tissue repair. The increase in neutrophil levels accompanied with a decrease in lymphocyte levels is characteristic for the inflammatory response. Therefore, neutrophil to lymphocyte ratio (NLR) comes out as a simple index of inflammation. In the literature, NLR was shown not only to be associated with surgical complications but also the length of hospital stays in certain surgeries. Another inflammatory marker index of hemogram is the platelet to lymphocyte ratio (PLR). As a result of endothelial tissue damage, platelets are gathered in the affected area. Therefore, an increase in the number of platelets is inevitable for inflammation. Hence, PLR appears to be another simple index of inflammation due to the increase of platelets and the decrease of lymphocytes. PLR has also shown to be associated with length of hospital stay in various surgeries. NLR and PLR are both newly recommended inflammatory markers to estimate the prognosis of surgical treatment in clinics. Investigations regarding NLR and PLR concerning prognosis of patients after surgeries including gynecological cancer, cardiac surgeries, and emergency surgeries are available in prior literature. Investigators aimed to investigate the possible effects of inflammatory parameters, that can be easily obtained from complete blood count in the post-operative first day of total laparoscopic hysterectomy, to the length of hospital stay in patients without any complications.


Recruitment information / eligibility

Status Completed
Enrollment 150
Est. completion date December 30, 2018
Est. primary completion date November 30, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria: - Patients whom have undergone TLH Exclusion Criteria: - Ureter injury - Bladder injury, - Bowel injury, - Superficial inferior mesenteric artery injury - Vaginal cuff hematoma - Vaginal cuff dehiscence - Endometriosis - Endometrial cancer - Cervical cancer - Chronic lymphocytic leukemia - Behçet disease - Electrolyte imbalance - Thyroid disease - Using anti-inflammatory medications - Having severe intraabdominal adhesions

Study Design


Intervention

Other:
hemogram inflammatory parameters
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gaziosmanpasa Research and Education Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Postoperative NLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days. NLR was calculated by dividing the absolute number of neutrophil to the absolute number of lymphocytes. 4 years
Primary Postoperative PLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days. PLR were calculated by dividing the absolute number of platelets to the absolute number of lymphocytes. 4 years
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