AnemiaNCT07798544
Preoperative Anaemia and Early Postoperative Complications After Major Gastrointestinal Surgery
An observational study of Anemia and Postoperative Complications, run by University of Ioannina at 1 site in Greece.
Trial summary
This prospective observational cohort study evaluated the association between preoperative anaemia and early postoperative morbidity in adults undergoing major gastrointestinal surgery at the University Hospital of Ioannina, Greece. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Anemia, Postoperative Complications
- How many people
- 146 participants
- Where
- 1 siteGreece
- Study dates
- 3 Feb 2025to 7 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Consecutive adult patients undergoing major abdominal gastrointestinal surgery at the University Hospital of Ioannina, Greece, during the predefined study period. Both elective and urgent procedures and open or laparoscopic approaches were included.
Who may be able to join
- Age >18 years
- Ability to provide written informed consent
- Undergoing major abdominal gastrointestinal surgery during the study period
- Elective or urgent surgery
- Open or laparoscopic surgical approach
Who cannot join
- Emergency surgery
- Organ transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Preoperative Anaemia and Early Postoperative Morbidity According to the Clavien-Dindo Classification After Major Gastrointestinal Surgery: a Prospective Observational Cohort Study
This prospective observational cohort study evaluated the association between preoperative anaemia and early postoperative morbidity in adults undergoing major gastrointestinal surgery at the University Hospital of Ioannina, Greece. Consecutive patients undergoing elective or urgent open or laparoscopic gastrointestinal surgery were enrolled. Preoperative anaemia was defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women. Patients were followed from surgery until hospital discharge or postoperative day 8, whichever occurred first. The primary outcome was any postoperative complication during this period. Secondary outcomes were major postoperative complications, defined as Clavien-Dindo grade III or higher, and discharge beyond the expected recovery period. The study also evaluated whether the association between preoperative anaemia and postoperative morbidity persisted after accounting for comorbidity, urgency of surgery, and surgical risk.
- Conditions
- Anemia, Postoperative Complications
- Keywords
- Preoperative anemia, Gastrointestinal surgery, Postoperative morbidity, Clavien-Dindo classification, Perioperative risk
- Medical subject headings
- Anemia, Postoperative Complications
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 |
|---|---|---|
| Preoperative Anaemia | Participants with preoperative anaemia, defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned. | |
| No Preoperative Anaemia | Participants without preoperative anaemia, defined as haemoglobin ≥13.0 g/dL in men and ≥12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Any Early Postoperative Complication
Occurrence of at least one postoperative complication recorded prospectively using a predefined list. Postoperative complications were graded according to the Clavien-Dindo classification.
Measured: From the day of surgery through postoperative day 8 or until earlier hospital discharge
Secondary outcomes (2)
Major Postoperative Complication
Occurrence of at least one postoperative complication classified as Clavien-Dindo grade III or higher.
Measured: From the day of surgery through postoperative day 8 or until earlier hospital discharge
Number of Participants Remaining Hospitalized Beyond Postoperative Day 8
Number of participants whose hospital stay extended beyond postoperative day 8, determined from the recorded hospital discharge date. Participants discharged on or before postoperative day 8 were not considered to have this outcome.
Measured: Postoperative day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2026
- Study start3 Feb 2025
- Primary completion31 Jul 2025
- Study completion7 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Agathi Karakosta, University of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07798544
- Sponsor's protocol ID
- 148/2023
- Status last verified
- Aug 2026
- First submitted
- 25 Aug 2026
- Last updated
- 1 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data are not planned to be shared because the original consent and study protocol did not include a data-sharing plan beyond the purposes of this study.
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Anaemia and Early Postoperative Morbidity According to the Clavien-Dindo Classification After Major Gastrointestinal Surgery: a Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07798544
- Acronym / sponsor ID
- 148/2023
- Conditions
- Anemia, Postoperative Complications
- Keywords
- Preoperative anemia, Gastrointestinal surgery, Postoperative morbidity, Clavien-Dindo classification, Perioperative risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University of IoanninaUniversity, hospital or other
- Study start
- 3 Feb 2025 (actual)
- Primary completion
- 31 Jul 2025 (actual)
- Study completion
- 7 Aug 2025 (actual)
- First posted
- 1 Sep 2026 (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.
This prospective observational cohort study evaluated the association between preoperative anaemia and early postoperative morbidity in adults undergoing major gastrointestinal surgery at the University Hospital of Ioannina, Greece. Consecutive patients undergoing elective or urgent open or laparoscopic gastrointestinal surgery were enrolled. Preoperative anaemia was defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women. Patients were followed from surgery until hospital discharge or postoperative day 8, whichever occurred first. The primary outcome was any postoperative complication during this period. Secondary outcomes were major postoperative complications, defined as Clavien-Dindo grade III or higher, and discharge beyond the expected recovery period. The study also evaluated whether the association between preoperative anaemia and postoperative morbidity persisted after accounting for comorbidity, urgency of surgery, and surgical risk.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative Anaemia | – | –Participants with preoperative anaemia, defined as haemoglobin <13.0 g/dL in men and <12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned. |
| No Preoperative Anaemia | – | –Participants without preoperative anaemia, defined as haemoglobin ≥13.0 g/dL in men and ≥12.0 g/dL in non-pregnant women before surgery. No study intervention was assigned. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients undergoing major abdominal gastrointestinal surgery at the University Hospital of Ioannina, Greece, during the predefined study period. Both elective and urgent procedures and open or laparoscopic approaches were included.
Key inclusion criteria (5 listed)
- Age >18 years
- Ability to provide written informed consent
- Undergoing major abdominal gastrointestinal surgery during the study period
- Elective or urgent surgery
- Open or laparoscopic surgical approach
Key exclusion criteria (2 listed)
- Emergency surgery
- Organ transplantation
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
Any Early Postoperative Complication
Time frame: From the day of surgery through postoperative day 8 or until earlier hospital discharge
Occurrence of at least one postoperative complication recorded prospectively using a predefined list. Postoperative complications were graded according to the Clavien-Dindo classification.
2 secondary outcomes
Major Postoperative Complication
Time frame: From the day of surgery through postoperative day 8 or until earlier hospital discharge
Number of Participants Remaining Hospitalized Beyond Postoperative Day 8
Time frame: Postoperative day 8
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 1 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data are not planned to be shared because the original consent and study protocol did not include a data-sharing plan beyond the purposes of this study.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Anemia and Postoperative Complications, run by University of Ioannina at 1 site in Greece.
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 5 inclusion and 2 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 1 Sep 2026. 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 Greece. 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?
Any Early Postoperative Complication (time frame: From the day of surgery through postoperative day 8 or until earlier hospital discharge). 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 1 Sep 2026.