Major Pelvic Hemorrhage in Complex Surgery

February 10, 2020 updated by: Acibadem University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34457
        • Acibadem Maslak Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients who had pelvic hemorrhage
Patients who had pelvic hemorrhage during complex abdomino-pelvic surgery
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peri-operative outcomes
Time Frame: Within postoperative day 30
Complication rate (Number of participants who had a complication divided by total number of participants)
Within postoperative day 30

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Acibadem University

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 19, 2018

Primary Completion (Actual)

October 19, 2018

Study Completion (Actual)

October 19, 2018

Study Registration Dates

First Submitted

February 7, 2020

First Submitted That Met QC Criteria

February 10, 2020

First Posted (Actual)

February 11, 2020

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018-6/17

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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