NCT07140991

Brief Summary

Esophagojejunostomy anastomosis is used in total gastrectomy surgeries. Anastomotic leakage is a serious complication seen after these surgeries and is associated with increased morbidity and mortality. Patients with older age and comorbidities have a higher risk of death following anastomotic leakage. Perioperative hyperglycemia is frequently observed in patients undergoing major abdominal surgery as a stress response to surgical trauma, leading to surgical complications through mechanisms such as glycogenolysis, lipolysis, gluconeogenesis, decreased insulin sensitivity, and increased insulin resistance. Hyperglycemia is known to increase the risk of postoperative infection, prolong hospital stay, and increase mortality. Additionally, recent studies have shown that it also increases the risk of anastomotic leakage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 26, 2025

Completed
Last Updated

August 26, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 21, 2025

Last Update Submit

August 21, 2025

Conditions

Keywords

hyperglycaemiatotal gastrectomyanastomotic leak

Outcome Measures

Primary Outcomes (1)

  • postoperative anastomotic leakage

    Patients who developed anastomotic leak after total gastrectomy

    30 days after surgery

Secondary Outcomes (2)

  • diabetic hyperglysemia

    intraoperative

  • non-diabetic hyperglysemia

    intraoperative

Study Arms (1)

hyperglycemia

Patients identified as hyperglycemic in the perioperative period

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The study was planned as a single-center retrospective study involving patients between the ages of 18 and 75 who underwent total gastrectomy and esophago-jejunostomy anastomosis for benign or malignant reasons.

You may qualify if:

  • elective total gastrectomy
  • anastomotic leak after surgery
  • age 18-75

You may not qualify if:

  • emergency procedure
  • \<18 years
  • \>75 years
  • ASA score \> 3

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Basaksehir Cam ve Sakura City Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

HyperglycemiaAnastomotic Leak

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Mustafa Çağrı Temel, MD

    Basaksehir Cam ve Sakura State Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 21, 2025

First Posted

August 26, 2025

Study Start

June 1, 2025

Primary Completion

July 20, 2025

Study Completion

August 20, 2025

Last Updated

August 26, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations