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NCT Number: NCT07798544

Preoperative Anaemia and Early Postoperative Complications After Major Gastrointestinal Surgery

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.

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Key information

Conditions

Anemia Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. Major 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 classified as Clavien-Dindo grade III or higher.

  2. Number of Participants Remaining Hospitalized Beyond Postoperative Day 8

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Ioannina

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 1, 2026
Registry last updated
Sep 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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