Major Pelvic Hemorrhage in Complex Surgery

NCT04264988 | Completed

• 1 other identifier: 2018-6/17
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Bleeding

Outcome Measures

Primary Outcomes (1)

• Peri-operative outcomes

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

  Within postoperative day 30

Study Arms (1)

Patients who had pelvic hemorrhage

Patients who had pelvic hemorrhage during complex abdomino-pelvic surgery

Procedure: Stopping of pelvic bleeding via several surgical methods

Interventions

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

Patients who had pelvic hemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient operated for complex abdominopelvic surgery including radical oncologic operations for the primary advanced or recurrent carcinoma of pelvic organs, pelvic cytoreduction, revisional/redo operations for failed ileal/colonic pouches, repair of the entero-enteral, entero-cutaneous, entero-vesical and entero-vaginal fistulas who had presacral bleeding in centers which had over 225 colorectal cases per year were included. Major pelvic bleeding is defined as symptomatic bleeding originating from pelvis, bleeding leading to transfusion of ≥2 units of whole blood or packed red cells; surgical site bleeding that requires a second intervention; or surgical site bleeding that is unexpected and prolonged and/or sufficiently large to cause hemodynamic instability with an associated decrease in hemoglobin ≥20 g/L.

You may qualify if:

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

You may not qualify if:

• Patients operated for palliative intent

Sponsors & Collaborators

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

Study Sites (1)

Acibadem Maslak Hospital

Istanbul, 34457, Turkey (Türkiye)

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: April 19, 2018
• Primary Completion: October 19, 2018
• Study Completion: October 19, 2018
• Last Updated: February 11, 2020

Record last verified: 2020-02

Locations

TU (1)