MorbidityNCT06648330
Blood Lactate Level With Paraaortic Lymph Node Dissection
An observational study of Morbidity and Gynaecologic Cancer, run by Duygu Akyol at 1 site in Turkey (Türkiye).
Trial summary
This study was designed as a prospective observational study. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Morbidity, Gynaecologic Cancer
- What is being tested?
- Paraaortic retroperitoneal lymph node dissection
- Type of treatment
- Surgery or procedure
- How many people
- 75 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 20 Sep 2024
- How long will I take part?
- 3 Months
- 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: Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection
Who may be able to join
- 18 years
- Patients undergoing paraaortic retroperitoneal lymph node dissection
Who cannot join
- Patients with chronic lung disease
- Patients with inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Blood Lactate Levels on Postoperative Gastrointestinal Morbidity After Paraaortic Retroperitoneal Lymph Node Dissection
This study was designed as a prospective observational study.
Read the detailed description
In this study, the investigator planned to evaluate the effect of blood lactate levels on postoperative gastrointestinal morbidity after paraaortic retroperitoneal lymph node dissection. In gynaecological surgeries, following the removal of the intestines from the surgical field, the retroperitoneal space is entered and the main vessels such as the vena cava inferior and aorta are accessed through the left or right approach depending on the experience and habit of the per-operative surgeon, and total systemic lymph node dissection or bulky lymph node excision is performed depending on the case. During the removal of the intestines from the surgical field, hypoperfusion may develop due to decreased blood flow to the intestines. for this purpose, the investigator planned to investigate the relationship between the change in blood gas lactate values and postoperative gastrointestinal complications in this process.
- Conditions
- Morbidity, Gynaecologic Cancer
- Being tested
- Paraaortic retroperitoneal lymph node dissection
- Keywords
- major open gynaecological cancer surgery, paraaortic lymph node dissection, gastrointestinal complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paraaortic retroperitoneal lymph node dissectionProcedure or surgery
The relationship between lactate level and mesenteric ischaemia in gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection will be evaluated.
| Study group | Role | What they receive |
|---|---|---|
| Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection | Paraaortic retroperitoneal lymph node dissection was performed in 75 patients with gynaecological cancer surgery Receives: Procedure: Paraaortic retroperitoneal lymph node dissection |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative lactate levels
Change from baseline in lactate levels in paraaortic lymph node dissection
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2024
- Study start1 Sep 2023
- Primary completion1 Sep 2024
- Study completion20 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MorbidityStudies 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
- Prospective
- Enrolment
- 75 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Duygu Akyol
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Duygu Akyol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06648330
- Sponsor's protocol ID
- 2023-544
- Status last verified
- May 2024
- First submitted
- 23 Sep 2024
- Last updated
- 18 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mothes H, Wickel J, Sponholz C, Lehmann T, Kaluza M, Zanow J, Doenst T. Monitoring of the Progression of the Perioperative Serum Lactate Concentration Improves the Accuracy of the Prediction of Acute Mesenteric Ischemia Development After Cardiovascular Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1792-1799. doi: 10.1053/j.jvca.2021.02.007. Epub 2021 Feb 8.
PubMed 33663981Oh TK, Song IA, Jeon YT. Peri-operative serum lactate level and postoperative 90-day mortality in a surgical ICU: A retrospective association study. Eur J Anaesthesiol. 2020 Jan;37(1):31-37. doi: 10.1097/EJA.0000000000001117.
PubMed 31724965Selcuk I, Oz M, Toyran A, Tatar I, Engin-Ustun Y, Demiryurek D. Para-aortic lymphadenectomy: step by step surgical education video. J Turk Ger Gynecol Assoc. 2021 Aug 31;22(3):253-254. doi: 10.4274/jtgga.galenos.2019.2019.0117. Epub 2019 Aug 9.
PubMed 31397548
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Blood Lactate Levels on Postoperative Gastrointestinal Morbidity After Paraaortic Retroperitoneal Lymph Node Dissection
- ClinicalTrials.gov ID
- NCT06648330
- Acronym / sponsor ID
- 2023-544
- Conditions
- Morbidity, Gynaecologic Cancer
- Keywords
- major open gynaecological cancer surgery, paraaortic lymph node dissection, gastrointestinal complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Duygu AkyolOther government
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 20 Sep 2024 (actual)
- First posted
- 18 Oct 2024 (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 study was designed as a prospective observational study.
Detailed description
In this study, the investigator planned to evaluate the effect of blood lactate levels on postoperative gastrointestinal morbidity after paraaortic retroperitoneal lymph node dissection. In gynaecological surgeries, following the removal of the intestines from the surgical field, the retroperitoneal space is entered and the main vessels such as the vena cava inferior and aorta are accessed through the left or right approach depending on the experience and habit of the per-operative surgeon, and total systemic lymph node dissection or bulky lymph node excision is performed depending on the case. During the removal of the intestines from the surgical field, hypoperfusion may develop due to decreased blood flow to the intestines. for this purpose, the investigator planned to investigate the relationship between the change in blood gas lactate values and postoperative gastrointestinal complications in this process.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection | – | Procedure: Paraaortic retroperitoneal lymph node dissectionParaaortic retroperitoneal lymph node dissection was performed in 75 patients with gynaecological cancer surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection
Key inclusion criteria (2 listed)
- 18 years
Key exclusion criteria (2 listed)
- Patients with chronic lung disease
- Patients with inflammatory bowel disease
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 |
|---|---|---|
| Paraaortic retroperitoneal lymph node dissectionThe relationship between lactate level and mesenteric ischaemia in gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection will be evaluated. | Procedure or surgery | Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection |
Primary outcome
intraoperative lactate levels
Time frame: intraoperatively
Change from baseline in lactate levels in paraaortic lymph node dissection
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 18 Oct 2024.
- Background: PubMed 33663981Mothes H, Wickel J, Sponholz C, Lehmann T, Kaluza M, Zanow J, Doenst T. Monitoring of the Progression of the Perioperative Serum Lactate Concentration Improves the Accuracy of the Prediction of Acute Mesenteric Ischemia Development After Cardiovascular Surgery. J Cardiothorac Vasc Anesth. 2021 Jun;35(6):1792-1799. doi: 10.1053/j.jvca.2021.02.007. Epub 2021 Feb 8.
- Results publication: PubMed 31724965Oh TK, Song IA, Jeon YT. Peri-operative serum lactate level and postoperative 90-day mortality in a surgical ICU: A retrospective association study. Eur J Anaesthesiol. 2020 Jan;37(1):31-37. doi: 10.1097/EJA.0000000000001117.
- Results publication: PubMed 31397548Selcuk I, Oz M, Toyran A, Tatar I, Engin-Ustun Y, Demiryurek D. Para-aortic lymphadenectomy: step by step surgical education video. J Turk Ger Gynecol Assoc. 2021 Aug 31;22(3):253-254. doi: 10.4274/jtgga.galenos.2019.2019.0117. Epub 2019 Aug 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Morbidity and Gynaecologic Cancer, run by Duygu Akyol 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 2 inclusion and 2 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 18 Oct 2024. 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?
intraoperative lactate levels (time frame: intraoperatively). 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 NCT06648330, which also lists 3 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 18 Oct 2024.