InflammationNCT05003297
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
An observational study of Inflammation and Hospital Stay, run by Gaziosmanpasa Research and Education Hospital.
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Inflammation, Hospital Stay, Total Laparoscopic Hysterectomy
- What is being tested?
- hemogram inflammatory parameters
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2014to 30 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients whom have undergone TLH without any postoperative surgical complications
Who may be able to join
- Patients whom have undergone TLH
Who cannot join
- Ureter injury
- Bladder injury,
- Bowel injury,
- Superficial inferior mesenteric artery injury
- Vaginal cuff hematoma
- Vaginal cuff dehiscence
Show all 15Show fewer
- Endometriosis
- Endometrial cancer
- Cervical cancer
- Chronic lymphocytic leukemia
- Behçet disease
- Electrolyte imbalance
- Thyroid disease
- Using anti-inflammatory medications
- Having severe intraabdominal adhesions
About this study
Official title: 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.
Read the 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.
- Conditions
- Inflammation, Hospital Stay, Total Laparoscopic Hysterectomy
- Being tested
- hemogram inflammatory parameters
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemogram inflammatory parametersOther
Neutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR)
| Study group | Role | What they receive |
|---|---|---|
| patients whom were hospitalized for 3 days or less | Not described Receives: Other: hemogram inflammatory parameters | |
| patients hospitalized for more than 3 days | Not described Receives: Other: hemogram inflammatory parameters |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
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.
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2021
- Study start1 Jan 2014
- Primary completion30 Nov 2018
- Study completion30 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05003297
- Sponsor's protocol ID
- GaziosmanpasaTREHd
- Status last verified
- Jul 2021
- First submitted
- 1 Aug 2021
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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?
- ClinicalTrials.gov ID
- NCT05003297
- Acronym / sponsor ID
- GaziosmanpasaTREHd
- Conditions
- Inflammation, Hospital Stay, Total Laparoscopic Hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 30 Nov 2018 (actual)
- Study completion
- 30 Dec 2018 (actual)
- First posted
- 12 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients whom were hospitalized for 3 days or less | – | Other: hemogram inflammatory parameters |
| patients hospitalized for more than 3 days | – | Other: hemogram inflammatory parameters |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients whom have undergone TLH without any postoperative surgical complications
Key inclusion criteria (1 listed)
- Patients whom have undergone TLH
Key exclusion criteria (15 listed)
- Ureter injury
- Bladder injury,
- Bowel injury,
- Superficial inferior mesenteric artery injury
- Vaginal cuff hematoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemogram inflammatory parametersNeutrophil to Lymphocyte Ratio (NLR) and Platelet to Lymphocyte Ratio (PLR) | Other | patients hospitalized for more than 3 days, patients whom were hospitalized for 3 days or less |
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammation and Hospital Stay, run by Gaziosmanpasa Research and Education Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.