Clinical trial NCT06648330: Blood Lactate Level With Paraaortic Lymph Node Dissection
Official title: The Effect of Blood Lactate Levels on Postoperative Gastrointestinal Morbidity After Paraaortic Retroperitoneal Lymph Node Dissection
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Morbidity
Gynaecologic Cancer
Keywords: major open gynaecological cancer surgery
paraaortic lymph node dissection
gastrointestinal complications
Lead sponsor: Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Sponsor class: OTHER_GOV
First posted: 2024-10-18
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

* 18 years

  * Patients undergoing paraaortic retroperitoneal lymph node dissection

Exclusion Criteria:

* Patients with chronic lung disease
* Patients with inflammatory bowel disease

Primary outcomes:
measure: intraoperative lactate levels
timeFrame: intraoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Duygu
Study officials:
References:
citation: 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.
citation: Oh 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.
citation: Selcuk 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.