Gynecologic DiseaseNCT04221308
Inflammatory Markers in Natural Orifice Hysterectomies
An observational study of Gynecologic Disease and Inflammation, run by Derince Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH). Between 2018 and 2019, data obtained from patients in the SLH and VH groups were reviewed retrospectively. Read more about this study
- Who is it for?
- Ages 45 to 60 years, women only
- Conditions the study is for
- Gynecologic Disease, Inflammation
- What is being tested?
- Single port laparoscopic systems
- Type of treatment
- Medical device
- How many people
- 134 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 15 Dec 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 45 to 60 years
- Women only
- No healthy volunteers
- Adult
Study population: women without any other medical problem who need hysterectomy for any condition
Who may be able to join
- hysterectomy requirement with any conditions in gynecologic diseases
Who cannot join
- patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases)
- the presence of active infection
- using of corticosteroid, acetylsalicylic acid, or anticoagulant
- cystocele or rectocele repair with mesh
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 Single Port Laparoscopic and Vaginal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).
Between 2018 and 2019, data obtained from patients in the SLH and VH 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.
- Conditions
- Gynecologic Disease, Inflammation
- Being tested
- Single port laparoscopic systems
- Keywords
- inflammation mediators, lymphocyte activation, natural orifice endoscopic surgery, neutrophil activation, platelet activation, vaginal hysterectomy
- 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.
Single port laparoscopic systemsDevice
The first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device
| Study group | Role | What they receive |
|---|---|---|
| single port laparoscopic hysterectomies | Between 2018 and 2019, data obtained from patients in the SLH and VH 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. Receives: Device: Single port laparoscopic systems | |
| Vaginal hysterectomies | Between 2018 and 2019, data obtained from patients in the SLH and VH 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.
Changes in hematocrit levels
Hematocrit (%) levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Measured: 1 day
Changes in hemoglobin levels
Hemoglobin levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Measured: 1 day
Changes in white blood cell levels
white blood cell (x103/mm3), in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Measured: 1 day
Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio
neutrophil-lymphocyte and platelet-lymphocyte ratio in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2020
- Study start1 Jan 2018
- Primary completion30 Nov 2019
- Study completion15 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (33)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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Derince Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mehmet ozsurmeli, Derince Training and Research Hospital
- Investigators
- mehmet ozsurmeli, Principal investigator, Derince Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04221308
- Sponsor's protocol ID
- 23068423
- Status last verified
- Jan 2020
- First submitted
- 1 Jan 2020
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Garry R. Health economics of hysterectomy. Best Pract Res Clin Obstet Gynaecol. 2005 Jun;19(3):451-65. doi: 10.1016/j.bpobgyn.2005.01.010. Epub 2005 Mar 2.
PubMed 15985258Yoon BS, Seong SJ, Kim IH, Song T, Kim ML, Kim MK. Operative outcomes of single-port-access laparoscopy-assisted vaginal hysterectomy compared with single-port-access total laparoscopic hysterectomy. Taiwan J Obstet Gynecol. 2014 Dec;53(4):486-9. doi: 10.1016/j.tjog.2013.07.003.
PubMed 25510688AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.
PubMed 21059487ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.
PubMed 20168127Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, Kluivers KB. Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):85-91. doi: 10.1097/AOG.0b013e31823d3b00.
PubMed 22183215Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.
PubMed 19588344Gynecol Surg. 2013; 10:117-122
J Obstet Gynaecol. 2019; 26:1-5.
Cruickshank 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 2167805Allendorf 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 9153168Lennard TW, Shenton BK, Borzotta A, Donnelly PK, White M, Gerrie LM, Proud G, Taylor RM. The influence of surgical operations on components of the human immune system. Br J Surg. 1985 Oct;72(10):771-6. doi: 10.1002/bjs.1800721002.
PubMed 2412626Iwase 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 16376940Ogawa K, Hirai M, Katsube T, Murayama M, Hamaguchi K, Shimakawa T, Naritake Y, Hosokawa T, Kajiwara T. Suppression of cellular immunity by surgical stress. Surgery. 2000 Mar;127(3):329-36. doi: 10.1067/msy.2000.103498.
PubMed 10715990Collet 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 8553203Sietses C, Wiezer MJ, Eijsbouts QA, van Leeuwen PA, Beelen RH, Meijer S, Cuesta MA. The influence of laparoscopic surgery on postoperative polymorphonuclear leukocyte function. Surg Endosc. 2000 Sep;14(9):812-6. doi: 10.1007/s004640010080.
PubMed 11000359
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Inflammatory Markers in Single Port Laparoscopic and Vaginal Hysterectomies: A Retrospective Study in Kocaeli, Northwest Turkey
- ClinicalTrials.gov ID
- NCT04221308
- Acronym / sponsor ID
- 23068423
- Conditions
- Gynecologic Disease, Inflammation
- Keywords
- inflammation mediators, lymphocyte activation, natural orifice endoscopic surgery, neutrophil activation, platelet activation, vaginal hysterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Derince Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 30 Nov 2019 (actual)
- Study completion
- 15 Dec 2019 (actual)
- First posted
- 9 Jan 2020 (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.
The authors aimed to detect inflammatory marker changes in two natural orifice hysterectomies: single-port laparoscopic hysterectomy (SLH) and vaginal hysterectomy (VH).
Between 2018 and 2019, data obtained from patients in the SLH and VH 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| single port laparoscopic hysterectomies | – | Device: Single port laparoscopic systemsBetween 2018 and 2019, data obtained from patients in the SLH and VH 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. |
| Vaginal hysterectomies | – | –Between 2018 and 2019, data obtained from patients in the SLH and VH 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
- Ages
- 45 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- women without any other medical problem who need hysterectomy for any condition
Key inclusion criteria (1 listed)
- hysterectomy requirement with any conditions in gynecologic diseases
Key exclusion criteria (4 listed)
- patients with a chronic disease (e.g., hypertension, diabetes mellitus, and rheumatologic, nephrological, and hematological diseases)
- the presence of active infection
- using of corticosteroid, acetylsalicylic acid, or anticoagulant
- cystocele or rectocele repair with mesh
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 |
|---|---|---|
| Single port laparoscopic systemsThe first assistant handles the scope from the patient's right side. The second assistant, who is positioned between the legs of the patient, inserts a uterine manipulator (Rumi System; Cooper Surgical, CT). At the beginning of the surgery, a 1.5 to 2.5 cm vertical incision is made within the umbilicus using the open Hasson approach. After the bottom retractor ring of the wound retractor component of the Octo-Port is inverted (DalimSurgNet, Seoul, Korea), it is inserted through the incision deep in the peritoneum. Carbon dioxide is insufflated through the gas valve of the Octo-Port to maintain intra-abdominal pressure at 10 to 12 mm Hg. Through the 10 mm channels of the Octo-Port, a 10 mm, 30° rigid laparoscope is introduced. Rigid laparoscopic instruments are introduced through the 5 mm channels of the Octo-Port. The utero-ovarian ligament or infundibulopelvic ligament, uterine vessels, and uterine ligaments are transected by using the 5 mm LigaSure vessel sealer device | Device | single port laparoscopic hysterectomies |
Primary outcome
Changes in hematocrit levels
Time frame: 1 day
Hematocrit (%) levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Changes in hemoglobin levels
Time frame: 1 day
Hemoglobin levels in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Changes in white blood cell levels
Time frame: 1 day
white blood cell (x103/mm3), in the first 24 hours after single port laparoscopic or vaginal hysterectomies were compared.
Changes in neutrophil-lymphocyte and platelet-lymphocyte ratio
Time frame: 1 day
neutrophil-lymphocyte and platelet-lymphocyte ratio in the first 24 hours after single port laparoscopic or vaginal 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 9 Jan 2020.
- Background: PubMed 15985258Garry R. Health economics of hysterectomy. Best Pract Res Clin Obstet Gynaecol. 2005 Jun;19(3):451-65. doi: 10.1016/j.bpobgyn.2005.01.010. Epub 2005 Mar 2.
- Background: PubMed 25510688Yoon BS, Seong SJ, Kim IH, Song T, Kim ML, Kim MK. Operative outcomes of single-port-access laparoscopy-assisted vaginal hysterectomy compared with single-port-access total laparoscopic hysterectomy. Taiwan J Obstet Gynecol. 2014 Dec;53(4):486-9. doi: 10.1016/j.tjog.2013.07.003.
- Background: PubMed 21059487AAGL Advancing Minimally Invasive Gynecology Worldwide. AAGL position statement: route of hysterectomy to treat benign uterine disease. J Minim Invasive Gynecol. 2011 Jan-Feb;18(1):1-3. doi: 10.1016/j.jmig.2010.10.001. Epub 2010 Nov 6. No abstract available.
- Background: PubMed 20168127ACOG Committee Opinion No. 444: choosing the route of hysterectomy for benign disease. Obstet Gynecol. 2009 Nov;114(5):1156-1158. doi: 10.1097/AOG.0b013e3181c33c72.
- Background: PubMed 22183215Nieboer TE, Hendriks JC, Bongers MY, Vierhout ME, Kluivers KB. Quality of life after laparoscopic and abdominal hysterectomy: a randomized controlled trial. Obstet Gynecol. 2012 Jan;119(1):85-91. doi: 10.1097/AOG.0b013e31823d3b00.
- Background: PubMed 19588344Nieboer TE, Johnson N, Lethaby A, Tavender E, Curr E, Garry R, van Voorst S, Mol BW, Kluivers KB. Surgical approach to hysterectomy for benign gynaecological disease. Cochrane Database Syst Rev. 2009 Jul 8;(3):CD003677. doi: 10.1002/14651858.CD003677.pub4.
- BackgroundGynecol Surg. 2013; 10:117-122
- BackgroundJ Obstet Gynaecol. 2019; 26:1-5.
- 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 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 2412626Lennard TW, Shenton BK, Borzotta A, Donnelly PK, White M, Gerrie LM, Proud G, Taylor RM. The influence of surgical operations on components of the human immune system. Br J Surg. 1985 Oct;72(10):771-6. doi: 10.1002/bjs.1800721002.
- Background: PubMed 16376940Iwase 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.
- 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.
mehmet ozsurmeli principal investigator
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 Derince Training and Research Hospital 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 4 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 9 Jan 2020. 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?
Changes in hematocrit levels (time frame: 1 day). The study lists 4 primary outcomes in all. 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 NCT04221308, which also lists 33 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 9 Jan 2020.