- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05003297
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) as an Inflammatory Markers to Predict Length of Hospital Stay After Total Laparoscopic Hysterectomy (TLH) for Benign Indications
August 23, 2021 updated by: Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
Can Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) be Used as Inflammatory Markers to Predict Length of Hospital Stay After Total Laparoscopic Hysterectomy (TLH) for Benign Indications?
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.
Study Overview
Status
Completed
Intervention / Treatment
Detailed 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.
Study Type
Observational
Enrollment (Actual)
150
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Patients whom have undergone TLH without any postoperative surgical complications
Description
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 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
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
patients whom were hospitalized for 3 days or less
|
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)
|
patients hospitalized for more than 3 days
|
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative NLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days.
Time Frame: 4 years
|
NLR was calculated by dividing the absolute number of neutrophil to the absolute number of lymphocytes.
|
4 years
|
Postoperative PLR values compared in patients who were hospitalized for more than 3 days and equal to or less than 3 days.
Time Frame: 4 years
|
PLR were calculated by dividing the absolute number of platelets to the absolute number of lymphocytes.
|
4 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 1, 2014
Primary Completion (Actual)
November 30, 2018
Study Completion (Actual)
December 30, 2018
Study Registration Dates
First Submitted
August 1, 2021
First Submitted That Met QC Criteria
August 5, 2021
First Posted (Actual)
August 12, 2021
Study Record Updates
Last Update Posted (Actual)
August 25, 2021
Last Update Submitted That Met QC Criteria
August 23, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GaziosmanpasaTREHd
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Yes
IPD Sharing Time Frame
The data is available now
IPD Sharing Supporting Information Type
- Study Protocol
- Statistical Analysis Plan (SAP)
- Clinical Study Report (CSR)
- Analytic Code
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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