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OpenTrials
Completed

NCT Number: NCT04264988

Major Pelvic Hemorrhage in Complex Surgery

Hemorrhage is a challenging complication of pelvic surgery. In this study, the investigators aimed to analyze the causes, management, and outcomes of major pelvic hemorrhage in patients undergoing complex abdomino-pelvic surgery. Participants who had a major intraoperative pelvic hemorrhage during complex abdomino-pelvic surgery at 11 tertiary referral centers were included. Participant characteristics, causes of hemorrhage, management strategies, and outcomes including morbidity and mortality analyses were evaluated.

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Key information

Conditions

Pelvic Bleeding

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Who can participate

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

Inclusion criteria

  • Patients who had major pelvic bleeding during complex abdominopelvic surgery
  • Patients operated in hospitals where over 225 colorectal cases were performed every year

Exclusion criteria

  • Patients operated for palliative intent

Treatment and study plan

Stopping of pelvic bleeding via several surgical methods

Procedure

Those surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those

Primary outcomes

  1. Peri-operative outcomes

    Time frame: Within postoperative day 30

    Complication rate (Number of participants who had a complication divided by total number of participants)

Sponsors and collaborators

Lead sponsor

Acibadem University

Other

Collaborators

  • Ankara University
  • Baskent University
  • Cukurova University
  • Dokuz Eylul University
  • Ege University
  • Gazi University
  • Gulhane Training and Research Hospital
  • Medicana Bursa Hospital
  • Medipol University
  • Pamukkale University
  • TOBB University

Registry information

Official study title

Management and Outcomes of Major Pelvic Hemorrhage in Patients Undergoing Complex Abdomino-Pelvic Surgery: A Cohort Study

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 11, 2020
Registry last updated
Feb 11, 2020

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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