HyperglycaemiaNCT07140991
The Effect of Perioperative Hyperglycemia on Anastomotic Leaks After Total Gastrectomy
An observational study of Hyperglycaemia and Total Gastrectomy, run by Taner Abdullah at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperglycaemia, Total Gastrectomy, Anastomotic Leaks
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2025to 20 Aug 2025
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- elective total gastrectomy
- anastomotic leak after surgery
- age 18-75
Who cannot join
- emergency procedure
- <18 years
- >75 years
- ASA score > 3
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Basaksehir Cam ve Sakura City Hospital
Istanbul
About this study
Official title: The Effect of Perioperative Hyperglycemia on Anastomotic Leaks in Patients Undergoing Total Gastrectomy: A Retrospective Cohort Study
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.
Read the detailed description
Although diabetes mellitus is a known risk factor for anastomotic leaks, there are few studies on the relationship between perioperative hyperglycemia and anastomotic leaks. The primary objective of our study was to demonstrate the relationship between hyperglycemia detected during anastomosis formation in the perioperative period and postoperative anastomotic leaks.
- Conditions
- Hyperglycaemia, Total Gastrectomy, Anastomotic Leaks
- Keywords
- hyperglycaemia, total gastrectomy, anastomotic leak
- Medical subject headings
- Hyperglycemia, Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| hyperglycemia | Patients identified as hyperglycemic in the perioperative period |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative anastomotic leakage
Patients who developed anastomotic leak after total gastrectomy
Measured: 30 days after surgery
Secondary outcomes (2)
diabetic hyperglysemia
Patients with diabetes but unregulated blood sugar
Measured: intraoperative
non-diabetic hyperglysemia
Patients without diabetes who became hyperglycemic due to surgical stress
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2025
- Study start1 Jun 2025
- Primary completion20 Jul 2025
- Study completion20 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperglycaemiaStudies 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
- Retrospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taner Abdullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Taner Abdullah, Istanbul Saglik Bilimleri University
- Investigators
- Mustafa Çağrı Temel, MD, Principal investigator, Basaksehir Cam ve Sakura State Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140991
- Sponsor's protocol ID
- 2025-183
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 26 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Perioperative Hyperglycemia on Anastomotic Leaks in Patients Undergoing Total Gastrectomy: A Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT07140991
- Acronym / sponsor ID
- 2025-183
- Conditions
- Hyperglycaemia, Total Gastrectomy, Anastomotic Leaks
- Keywords
- hyperglycaemia, total gastrectomy, anastomotic leak
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Taner AbdullahUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 20 Jul 2025 (actual)
- Study completion
- 20 Aug 2025 (actual)
- First posted
- 26 Aug 2025 (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.
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.
Detailed description
Although diabetes mellitus is a known risk factor for anastomotic leaks, there are few studies on the relationship between perioperative hyperglycemia and anastomotic leaks. The primary objective of our study was to demonstrate the relationship between hyperglycemia detected during anastomosis formation in the perioperative period and postoperative anastomotic leaks.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hyperglycemia | – | –Patients identified as hyperglycemic in the perioperative period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- elective total gastrectomy
- anastomotic leak after surgery
- age 18-75
Key exclusion criteria (4 listed)
- emergency procedure
- <18 years
- >75 years
- ASA score > 3
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
postoperative anastomotic leakage
Time frame: 30 days after surgery
Patients who developed anastomotic leak after total gastrectomy
2 secondary outcomes
diabetic hyperglysemia
Time frame: intraoperative
non-diabetic hyperglysemia
Time frame: intraoperative
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 26 Aug 2025.
- 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.
Mustafa Çağrı Temel, MD principal investigator
Basaksehir Cam ve Sakura State Hospital
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 Hyperglycaemia and Total Gastrectomy, run by Taner Abdullah 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 3 inclusion and 4 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 26 Aug 2025. 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?
postoperative anastomotic leakage (time frame: 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2025.