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Preoperative Anaemia and Early Postoperative Complications After Major Gastrointestinal Surgery

Preoperative Anaemia and Early Postoperative Morbidity According to the Clavien-Dindo Classification After Major Gastrointestinal Surgery: a Prospective Observational Cohort Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07798544
Enrollment
146
Registered
2026-09-01
Start date
2025-02-03
Completion date
2025-08-07
Last updated
2026-09-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anemia, Postoperative Complications

Keywords

Preoperative anemia, Gastrointestinal surgery, Postoperative morbidity, Clavien-Dindo classification, Perioperative risk

Brief 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. 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.

Interventions

None listed

Sponsors

University of Ioannina
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Emergency surgery * Organ transplantation

Design outcomes

Primary

MeasureTime frameDescription
Any Early Postoperative ComplicationFrom the day of surgery through postoperative day 8 or until earlier hospital dischargeOccurrence of at least one postoperative complication recorded prospectively using a predefined list. Postoperative complications were graded according to the Clavien-Dindo classification.

Secondary

MeasureTime frameDescription
Major Postoperative ComplicationFrom the day of surgery through postoperative day 8 or until earlier hospital dischargeOccurrence of at least one postoperative complication classified as Clavien-Dindo grade III or higher.
Number of Participants Remaining Hospitalized Beyond Postoperative Day 8Postoperative day 8Number 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.

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 2, 2026