Major Pelvic Hemorrhage in Complex Surgery

Pelvic Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04264988
• Other study ID #: 2018-6/17
• Status: Completed
• Start date: April 19, 2018
• Est. completion date: October 19, 2018

Study information

• Verified date: February 2020
• Source: Acibadem University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: October 19, 2018
• Est. primary completion date: October 19, 2018
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hemorrhage
• Pelvic Bleeding

Intervention

Procedure:
• Stopping of pelvic bleeding via several surgical methods
Those surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those

Locations

Country	Name	City	State
Turkey	Acibadem Maslak Hospital	Istanbul

Sponsors (12)

Lead Sponsor	Collaborator
Acibadem University	Ankara University, Baskent University, Bursa Medicana Hospital, Cukurova University, Dokuz Eylul University, Ege University, Gazi University, Medipol University, Pamukkale University, SBU Gulhane Education and Training Hospital, TOBB University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peri-operative outcomes	Complication rate (Number of participants who had a complication divided by total number of participants)	Within postoperative day 30