Gynecologic DiseaseNCT04184765
Inflammatory Markers in Hysterectomies
An observational study of Gynecologic Disease and Inflammation, run by mehmet ozsurmeli at 1 site in Turkey (Türkiye).
Trial summary
This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital. The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Gynecologic Disease, Inflammation
- How many people
- 212 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 30 Sep 2019
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: women without any other medical problem who need hysterectomy for any condition
Who may be able to join
- total or abdominal hysterectomy
Who cannot join
- hypertension, diabetes mellitus, rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Derince Training and Research Hospital
Kocaeli, 1260
About this study
Official title: Evaluation of Inflammatory Markers in Laparoscopic and Abdominal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital.
The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Our hospital is a 50-bed tertiary reference center where approximately 3,500 births per year occur, and about 500 gynecological-oncological surgeries are performed annually. The records of patients who underwent LH and AH were reviewed retrospectively. Preoperative and postoperative blood values in the first 24 hours after surgery were compared: hematocrit (HCT), hemoglobin (HB), WBC, PLR, and NLR values were compared as well as the demographic characteristics of the patients who underwent these procedures. In addition, to evaluate the effect of ovaries on the inflammatory markers, the patients were divided into two groups: oophorectomy and non-oophorectomy.
Read more
In our clinic, the decision to perform a hysterectomy is made by the weekly gynecology council. The type of surgery is determined according to the clinical condition of the patient, the gynecological examination, and the patient's request. In general, open surgery is preferred in patients with giant fibroids, many previous surgeries, and immobile uteri. Conditions such as dysfunctional uterine bleeding, cervical intraepithelial neoplasms, and uterine descensus indicate the need for LH. In cases where there is no clinical suspicion, oophorectomy is performed according to the patients' wishes.
In benign cases, the preferred type of hysterectomy is type 1 extra facial hysterectomy. In LH, the procedure is performed as follows: The uterine manipulator is inserted vaginally. First, a Veress needle and then a trocar are entered through the umbilicus. The abdomen is insufflated with carbon dioxide, and the appropriate number of ports is placed. Uterine ligaments and vessels are cut by using bipolar energy. The uterus is removed through the vagina, and the vaginal cuff is sutured laparoscopically.
Patients with chronic diseases (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study. Bladder and bowel injuries, blood transfusion requirements, wound infection and hematoma, postoperative respiratory system complications (e.g., atelectasis) were evaluated as surgical complications.
- Conditions
- Gynecologic Disease, Inflammation
- Keywords
- hysterectomies, inflammation mediators, lymphocyte
- Medical subject headings
- Genital Diseases, Female, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Total laparoscopic hysterectomies | Between 2018 and 2019, data obtained from patients in the LH and AH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR) and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients. | |
| Abdominal hysterectomies | Between 2018 and 2019, data obtained from patients in the LH and AH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR) and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of inflammatory markers in abdominal and laparoscopic hysterectomies
Preoperative and postoperative hematocrit (%), hematocrit (%), hemoglobin (gram/deciliter), white blood cell (x103/mm3), PLR, and NLR values values in the first 24 hours after laparoscopic or abdominal hysterectomies were compared.
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2019
- Study start1 Jan 2018
- Primary completion31 Aug 2019
- Study completion30 Sep 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (34)Papers the sponsor has linked to this study.
- Other trials for Gynecologic DiseaseStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- mehmet ozsurmeli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mehmet ozsurmeli, Derince Training and Research Hospital
- Investigators
- Ünal Türkay, MD, Study director, Derince Training and Research HospitalBahar Salıcı, MD, Study chair, Derince Training and Research HospitalMehmet Salıcı, MD, Study chair, Derince Training and Research HospitalKaranfil Nisan Bölge, MD, Study chair, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04184765
- Sponsor's protocol ID
- 35753575
- Status last verified
- Dec 2019
- First submitted
- 27 Nov 2019
- Last updated
- 11 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
PubMed 26264829Allendorf JD, Bessler M, Whelan RL, Trokel M, Laird DA, Terry MB, Treat MR. Postoperative immune function varies inversely with the degree of surgical trauma in a murine model. Surg Endosc. 1997 May;11(5):427-30. doi: 10.1007/s004649900383.
PubMed 9153168Chapron C, Fauconnier A, Goffinet F, Breart G, Dubuisson JB. Laparoscopic surgery is not inherently dangerous for patients presenting with benign gynaecologic pathology. Results of a meta-analysis. Hum Reprod. 2002 May;17(5):1334-42. doi: 10.1093/humrep/17.5.1334.
PubMed 11980761Collet D, Vitale GC, Reynolds M, Klar E, Cheadle WG. Peritoneal host defenses are less impaired by laparoscopy than by open operation. Surg Endosc. 1995 Oct;9(10):1059-64. doi: 10.1007/BF00188987.
PubMed 8553203Cruickshank AM, Fraser WD, Burns HJ, Van Damme J, Shenkin A. Response of serum interleukin-6 in patients undergoing elective surgery of varying severity. Clin Sci (Lond). 1990 Aug;79(2):161-5. doi: 10.1042/cs0790161.
PubMed 2167805Faist E, Kupper TS, Baker CC, Chaudry IH, Dwyer J, Baue AE. Depression of cellular immunity after major injury. Its association with posttraumatic complications and its reversal with immunomodulation. Arch Surg. 1986 Sep;121(9):1000-5. doi: 10.1001/archsurg.1986.01400090026004.
PubMed 3741094Fornara P, Doehn C, Seyfarth M, Jocham D. Why is urological laparoscopy minimally invasive? Eur Urol. 2000 Mar;37(3):241-50. doi: 10.1159/000052351.
PubMed 10720847Gibson PH, Croal BL, Cuthbertson BH, Small GR, Ifezulike AI, Gibson G, Jeffrey RR, Buchan KG, El-Shafei H, Hillis GS. Preoperative neutrophil-lymphocyte ratio and outcome from coronary artery bypass grafting. Am Heart J. 2007 Nov;154(5):995-1002. doi: 10.1016/j.ahj.2007.06.043.
PubMed 17967611Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, Osborne H, Bouchier-Hayes D. Reduced postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991 Feb;78(2):160-2. doi: 10.1002/bjs.1800780209.
PubMed 1826624Gupta A, Watson DI. Effect of laparoscopy on immune function. Br J Surg. 2001 Oct;88(10):1296-306. doi: 10.1046/j.0007-1323.2001.01860.x.
PubMed 11578282Horne BD, Anderson JL, John JM, Weaver A, Bair TL, Jensen KR, Renlund DG, Muhlestein JB; Intermountain Heart Collaborative Study Group. Which white blood cell subtypes predict increased cardiovascular risk? J Am Coll Cardiol. 2005 May 17;45(10):1638-43. doi: 10.1016/j.jacc.2005.02.054. Epub 2005 Apr 25.
PubMed 15893180Imtiaz F, Shafique K, Mirza SS, Ayoob Z, Vart P, Rao S. Neutrophil lymphocyte ratio as a measure of systemic inflammation in prevalent chronic diseases in Asian population. Int Arch Med. 2012 Jan 26;5(1):2. doi: 10.1186/1755-7682-5-2.
PubMed 22281066Iwase M, Kondo G, Watanabe H, Takaoka S, Uchida M, Ohashi M, Nagumo M. Regulation of Fas-mediated apoptosis in neutrophils after surgery-induced acute inflammation. J Surg Res. 2006 Jul;134(1):114-23. doi: 10.1016/j.jss.2005.10.013. Epub 2005 Dec 27.
PubMed 16376940Joris J, Cigarini I, Legrand M, Jacquet N, De Groote D, Franchimont P, Lamy M. Metabolic and respiratory changes after cholecystectomy performed via laparotomy or laparoscopy. Br J Anaesth. 1992 Oct;69(4):341-5. doi: 10.1093/bja/69.4.341.
PubMed 1419439Khatib G, Soysal C, Cetin C, Gulec UK, Guzel AB, Keskin N, Vardar MA, Gumurdulu D. Does preoperative neutrophil to lymphocyte or platelet to lymphocyte ratios have a role in predicting borderline ovarian tumors? J Ovarian Res. 2016 Nov 8;9(1):78. doi: 10.1186/s13048-016-0283-2.
PubMed 27821183
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inflammatory Markers in Laparoscopic and Abdominal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
- ClinicalTrials.gov ID
- NCT04184765
- Acronym / sponsor ID
- 35753575
- Conditions
- Gynecologic Disease, Inflammation
- Keywords
- hysterectomies, inflammation mediators, lymphocyte
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- mehmet ozsurmeliUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 30 Sep 2019 (actual)
- First posted
- 4 Dec 2019 (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.
This retrospective study was conducted in the obstetrics and gynecology clinic at Derince Training and Research Hospital.
The study group was identified as patients who underwent hysterectomy between 2018 and 2019. Our hospital is a 50-bed tertiary reference center where approximately 3,500 births per year occur, and about 500 gynecological-oncological surgeries are performed annually. The records of patients who underwent LH and AH were reviewed retrospectively. Preoperative and postoperative blood values in the first 24 hours after surgery were compared: hematocrit (HCT), hemoglobin (HB), WBC, PLR, and NLR values were compared as well as the demographic characteristics of the patients who underwent these procedures. In addition, to evaluate the effect of ovaries on the inflammatory markers, the patients were divided into two groups: oophorectomy and non-oophorectomy.
In our clinic, the decision to perform a hysterectomy is made by the weekly gynecology council. The type of surgery is determined according to the clinical condition of the patient, the gynecological examination, and the patient's request. In general, open surgery is preferred in patients with giant fibroids, many previous surgeries, and immobile uteri. Conditions such as dysfunctional uterine bleeding, cervical intraepithelial neoplasms, and uterine descensus indicate the need for LH. In cases where there is no clinical suspicion, oophorectomy is performed according to the patients' wishes.
In benign cases, the preferred type of hysterectomy is type 1 extra facial hysterectomy. In LH, the procedure is performed as follows: The uterine manipulator is inserted vaginally. First, a Veress needle and then a trocar are entered through the umbilicus. The abdomen is insufflated with carbon dioxide, and the appropriate number of ports is placed. Uterine ligaments and vessels are cut by using bipolar energy. The uterus is removed through the vagina, and the vaginal cuff is sutured laparoscopically.
Patients with chronic diseases (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study. Bladder and bowel injuries, blood transfusion requirements, wound infection and hematoma, postoperative respiratory system complications (e.g., atelectasis) were evaluated as surgical complications.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Total laparoscopic hysterectomies | – | –Between 2018 and 2019, data obtained from patients in the LH and AH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR) and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients. |
| Abdominal hysterectomies | – | –Between 2018 and 2019, data obtained from patients in the LH and AH groups were reviewed retrospectively. The preoperative and postoperative hematocrit (HCT), hemoglobin (HB), white blood cell (WBC), platelet (PLR) and neutrophil-lymphocyte (NLR) ratios and values were compared as well as the demographic characteristics of the patients. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- women without any other medical problem who need hysterectomy for any condition
Key inclusion criteria (1 listed)
- total or abdominal hysterectomy
Key exclusion criteria (1 listed)
- hypertension, diabetes mellitus, rheumatologic, nephrological, and hematological diseases), the presence of active infection, corticosteroid use, acetylsalicylic acid, and anticoagulant use were not included in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of inflammatory markers in abdominal and laparoscopic hysterectomies
Time frame: 24 hours post-surgery
Preoperative and postoperative hematocrit (%), hematocrit (%), hemoglobin (gram/deciliter), white blood cell (x103/mm3), PLR, and NLR values values in the first 24 hours after laparoscopic or abdominal hysterectomies were compared.
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 11 Dec 2019.
- Background: PubMed 26264829Aarts JW, Nieboer TE, Johnson N, Tavender E, Garry R, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2015 Aug 12;2015(8):CD003677. doi: 10.1002/14651858.CD003677.pub5.
- Background: PubMed 9153168Allendorf JD, Bessler M, Whelan RL, Trokel M, Laird DA, Terry MB, Treat MR. Postoperative immune function varies inversely with the degree of surgical trauma in a murine model. Surg Endosc. 1997 May;11(5):427-30. doi: 10.1007/s004649900383.
- Background: PubMed 11980761Chapron C, Fauconnier A, Goffinet F, Breart G, Dubuisson JB. Laparoscopic surgery is not inherently dangerous for patients presenting with benign gynaecologic pathology. Results of a meta-analysis. Hum Reprod. 2002 May;17(5):1334-42. doi: 10.1093/humrep/17.5.1334.
- Background: PubMed 8553203Collet D, Vitale GC, Reynolds M, Klar E, Cheadle WG. Peritoneal host defenses are less impaired by laparoscopy than by open operation. Surg Endosc. 1995 Oct;9(10):1059-64. doi: 10.1007/BF00188987.
- Background: PubMed 2167805Cruickshank AM, Fraser WD, Burns HJ, Van Damme J, Shenkin A. Response of serum interleukin-6 in patients undergoing elective surgery of varying severity. Clin Sci (Lond). 1990 Aug;79(2):161-5. doi: 10.1042/cs0790161.
- Background: PubMed 3741094Faist E, Kupper TS, Baker CC, Chaudry IH, Dwyer J, Baue AE. Depression of cellular immunity after major injury. Its association with posttraumatic complications and its reversal with immunomodulation. Arch Surg. 1986 Sep;121(9):1000-5. doi: 10.1001/archsurg.1986.01400090026004.
- Background: PubMed 10720847Fornara P, Doehn C, Seyfarth M, Jocham D. Why is urological laparoscopy minimally invasive? Eur Urol. 2000 Mar;37(3):241-50. doi: 10.1159/000052351.
- Background: PubMed 17967611Gibson PH, Croal BL, Cuthbertson BH, Small GR, Ifezulike AI, Gibson G, Jeffrey RR, Buchan KG, El-Shafei H, Hillis GS. Preoperative neutrophil-lymphocyte ratio and outcome from coronary artery bypass grafting. Am Heart J. 2007 Nov;154(5):995-1002. doi: 10.1016/j.ahj.2007.06.043.
- Background: PubMed 1826624Grace PA, Quereshi A, Coleman J, Keane R, McEntee G, Broe P, Osborne H, Bouchier-Hayes D. Reduced postoperative hospitalization after laparoscopic cholecystectomy. Br J Surg. 1991 Feb;78(2):160-2. doi: 10.1002/bjs.1800780209.
- Background: PubMed 11578282Gupta A, Watson DI. Effect of laparoscopy on immune function. Br J Surg. 2001 Oct;88(10):1296-306. doi: 10.1046/j.0007-1323.2001.01860.x.
- Background: PubMed 15893180Horne BD, Anderson JL, John JM, Weaver A, Bair TL, Jensen KR, Renlund DG, Muhlestein JB; Intermountain Heart Collaborative Study Group. Which white blood cell subtypes predict increased cardiovascular risk? J Am Coll Cardiol. 2005 May 17;45(10):1638-43. doi: 10.1016/j.jacc.2005.02.054. Epub 2005 Apr 25.
- Background: PubMed 22281066Imtiaz F, Shafique K, Mirza SS, Ayoob Z, Vart P, Rao S. Neutrophil lymphocyte ratio as a measure of systemic inflammation in prevalent chronic diseases in Asian population. Int Arch Med. 2012 Jan 26;5(1):2. doi: 10.1186/1755-7682-5-2.
- Individual participant dataSharing planned: No
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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.
Ünal Türkay, MD study director
Derince Training and Research Hospital
Bahar Salıcı, MD study chair
Derince Training and Research Hospital
Mehmet Salıcı, MD study chair
Derince Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gynecologic Disease and Inflammation, run by mehmet ozsurmeli at 1 site in Turkey (Türkiye).
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 1 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 11 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change of inflammatory markers in abdominal and laparoscopic hysterectomies (time frame: 24 hours post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04184765, which also lists 34 linked publications.
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 11 Dec 2019.