Laparoscopic HysterectomyNCT04366375
Pentraxin-3 in Hysterectomy Patients
An observational study of Laparoscopic Hysterectomy and Abdominal Hysterectomy, run by Muğla Sıtkı Koçman University.
Trial summary
Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Laparoscopic Hysterectomy, Abdominal Hysterectomy
- What is being tested?
- PTX-3
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 13 Jan 2015to 7 Dec 2015
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: A total of 40 patients, composed of 20 TLH+BSO patients and 20 TAH+BSO patients were included into the study.
Who may be able to join
- ·TLH+BSO patients and TAH+BSO patients
Who cannot join
- History of a chronic disease (coronary artery disease, diabetes mellitus, hypertension, coronary liver failures, chronic kidney disease, chronic respiratory diseases, connective tissue disorders) which may affect levels of PTX-3 and other inflammatory markers.
- Prior surgery due to malignancy.
- History of an intra-abdominal surgery, except for cesarean section.
- History of any disease which may lead to intra-abdominal adhesions (endometriosis, past pelvic infection).
About this study
Official title: Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy
Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy
Read the detailed description
Acute trauma and major surgeries activate a series of cascades to evoke systemic inflammatory response. The magnitude of the resulting inflammatory response is proportional to the severity of the tissue trauma. Abdominal or laparoscopic technique is widely used for the purpose of hysterectomy surgery. It is crucial for many aspects to compare these two techniques of hysterectomy in terms of the surgery-induced trauma.
In this study, the severity of the inflammatory response resulting from the tissue trauma due to the techniques of TLH+BSO and TAH+BSO applied in our department were compared based on the PTX-3 molecule.
- Conditions
- Laparoscopic Hysterectomy, Abdominal Hysterectomy
- Being tested
- PTX-3
- Keywords
- Pentraxin-3, tissue trauma, hysterectomy, neutrophil to lymphocyte ratio
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTX-3Diagnostic test
Pentraxin-3 ng/mL PTX-3 levels were measured using human PTX3 ELISA Kit 96 Tests/Box (Cat. No: CK-E90303) (Hangzhou Eastbiopharm Co.,Ltd., PRC) read by a ELISA device matching with the kit. For the purpose of measurement, microplate washer RT 2600 device and Rayto microplate reader RT 2100C device were used.
| Study group | Role | What they receive |
|---|---|---|
| TLH+BSO | Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20 Receives: Diagnostic Test: PTX-3 | |
| TAH + BSO | Total Abdominal Hysterectomy + BSO N=20 Receives: Diagnostic Test: PTX-3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pentraxin-3 level
Pentraxin-3 ng/mL
Measured: Before 24 hours preoperatively and upto 24 hours postoperatively
Secondary outcomes (1)
(NLR)
neutrophile/lymphocyte ratio
Measured: Up to 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start13 Jan 2015
- Primary completion7 Dec 2015
- Study completion7 Dec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic HysterectomyStudies 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-control
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Sezgin, Muğla Sıtkı Koçman University
- Investigators
- Burak SEZGİN, Dr, Principal investigator, Mugla Sıtkı Kocman University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366375
- Sponsor's protocol ID
- 19.03.15-58-56
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 30 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT04366375
- Acronym / sponsor ID
- 19.03.15-58-56
- Conditions
- Laparoscopic Hysterectomy, Abdominal Hysterectomy
- Keywords
- Pentraxin-3, tissue trauma, hysterectomy, neutrophil to lymphocyte ratio
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 13 Jan 2015 (actual)
- Primary completion
- 7 Dec 2015 (actual)
- Study completion
- 7 Dec 2015 (actual)
- First posted
- 28 Apr 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.
Comparison of the Tissue Trauma Markers Following Total Laparoscopic Hysterectomy vs Total Abdominal Hysterectomy
Detailed description
Acute trauma and major surgeries activate a series of cascades to evoke systemic inflammatory response. The magnitude of the resulting inflammatory response is proportional to the severity of the tissue trauma. Abdominal or laparoscopic technique is widely used for the purpose of hysterectomy surgery. It is crucial for many aspects to compare these two techniques of hysterectomy in terms of the surgery-induced trauma.
In this study, the severity of the inflammatory response resulting from the tissue trauma due to the techniques of TLH+BSO and TAH+BSO applied in our department were compared based on the PTX-3 molecule.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TLH+BSO | – | Diagnostic Test: PTX-3Total Laparoscopic Hysterectomy + Bilateral Salpingo-Oophorectomy N=20 |
| TAH + BSO | – | Diagnostic Test: PTX-3Total Abdominal Hysterectomy + BSO N=20 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 40 patients, composed of 20 TLH+BSO patients and 20 TAH+BSO patients were included into the study.
Key inclusion criteria (1 listed)
- ·TLH+BSO patients and TAH+BSO patients
Key exclusion criteria (4 listed)
- History of a chronic disease (coronary artery disease, diabetes mellitus, hypertension, coronary liver failures, chronic kidney disease, chronic respiratory diseases, connective tissue disorders) which may affect levels of PTX-3 and other inflammatory markers.
- Prior surgery due to malignancy.
- History of an intra-abdominal surgery, except for cesarean section.
- History of any disease which may lead to intra-abdominal adhesions (endometriosis, past pelvic infection).
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 |
|---|---|---|
| PTX-3Pentraxin-3 ng/mL PTX-3 levels were measured using human PTX3 ELISA Kit 96 Tests/Box (Cat. No: CK-E90303) (Hangzhou Eastbiopharm Co.,Ltd., PRC) read by a ELISA device matching with the kit. For the purpose of measurement, microplate washer RT 2600 device and Rayto microplate reader RT 2100C device were used. | Diagnostic test | TAH + BSO, TLH+BSO |
Primary outcome
Pentraxin-3 level
Time frame: Before 24 hours preoperatively and upto 24 hours postoperatively
Pentraxin-3 ng/mL
1 secondary outcome
(NLR)
Time frame: Up to 24 hours postoperative
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 30 Apr 2020.
- Individual participant dataSharing planned: Undecided. undecided
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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.
Burak SEZGİN, Dr principal investigator
Mugla Sıtkı Kocman University Faculty of Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Hysterectomy and Abdominal Hysterectomy, run by Muğla Sıtkı Koçman University.
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 30 Apr 2020. 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?
Pentraxin-3 level (time frame: Before 24 hours preoperatively and upto 24 hours postoperatively). 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 30 Apr 2020; AzTrials last refreshed its copy on 1 Nov 2026.