NCT06648330

Brief Summary

This study was designed as a prospective observational study.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2024

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2024

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 18, 2024

Completed
Last Updated

October 18, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

September 23, 2024

Last Update Submit

October 17, 2024

Conditions

Keywords

major open gynaecological cancer surgeryparaaortic lymph node dissectiongastrointestinal complications

Outcome Measures

Primary Outcomes (1)

  • intraoperative lactate levels

    Change from baseline in lactate levels in paraaortic lymph node dissection

    intraoperatively

Study Arms (1)

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

Interventions

The relationship between lactate level and mesenteric ischaemia in gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection will be evaluated.

Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Gynaecological cancer surgeries with paraaortic retroperitoneal lymph node dissection

You may qualify if:

  • years
  • Patients undergoing paraaortic retroperitoneal lymph node dissection

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duygu

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 33663981BACKGROUND
  • 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.

  • 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.

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Months
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 23, 2024

First Posted

October 18, 2024

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

September 20, 2024

Last Updated

October 18, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations