Blood Lactate Level With Paraaortic Lymph Node Dissection

October 17, 2024 updated by: Duygu Akyol

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Duygu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection

Description

Inclusion Criteria:

  • 18 years

    • Patients undergoing paraaortic retroperitoneal lymph node dissection

Exclusion Criteria:

  • Patients with chronic lung disease
  • Patients with inflammatory bowel disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection
Paraaortic retroperitoneal lymph node dissection was performed in 75 patients with gynaecological cancer surgery
Procedure: Paraaortic retroperitoneal lymph node dissection
The relationship between lactate level and mesenteric ischaemia in gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection will be evaluated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
intraoperative lactate levels
Time Frame: intraoperatively
Change from baseline in lactate levels in paraaortic lymph node dissection
intraoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duygu Akyol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 20, 2024

Study Registration Dates

First Submitted

September 23, 2024

First Submitted That Met QC Criteria

October 17, 2024

First Posted (Actual)

October 18, 2024

Study Record Updates

Last Update Posted (Actual)

October 18, 2024

Last Update Submitted That Met QC Criteria

October 17, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023-544

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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