Pelvic BleedingNCT04264988
Major Pelvic Hemorrhage in Complex Surgery
An observational study of Pelvic Bleeding, run by Acibadem University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pelvic Bleeding
- What is being tested?
- Stopping of pelvic bleeding via several surgical methods
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 19 Apr 2018to 19 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- Patients who had major pelvic bleeding during complex abdominopelvic surgery
- Patients operated in hospitals where over 225 colorectal cases were performed every year
Who cannot join
- Patients operated for palliative intent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Pelvic Bleeding
- Being tested
- Stopping of pelvic bleeding via several surgical methods
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stopping of pelvic bleeding via several surgical methodsProcedure or surgery
Those surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those
| Study group | Role | What they receive |
|---|---|---|
| Patients who had pelvic hemorrhage | Patients who had pelvic hemorrhage during complex abdomino-pelvic surgery Receives: Procedure: Stopping of pelvic bleeding via several surgical methods |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peri-operative outcomes
Complication rate (Number of participants who had a complication divided by total number of participants)
Measured: Within postoperative day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start19 Apr 2018
- Primary completion19 Oct 2018
- Study completion19 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pelvic BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Collaborators
- Medicana Bursa Hospital, Dokuz Eylul University, Cukurova University, Pamukkale University, Ankara University, TOBB University, Gazi University, Baskent University, Ege University, Medipol University, Gulhane Training and Research Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04264988
- Sponsor's protocol ID
- 2018-6/17
- Status last verified
- Feb 2020
- First submitted
- 7 Feb 2020
- Last updated
- 11 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management and Outcomes of Major Pelvic Hemorrhage in Patients Undergoing Complex Abdomino-Pelvic Surgery: A Cohort Study
- ClinicalTrials.gov ID
- NCT04264988
- Acronym / sponsor ID
- 2018-6/17
- Conditions
- Pelvic Bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Collaborators
- Medicana Bursa Hospital, Dokuz Eylul University, Cukurova University, Pamukkale University, Ankara University, TOBB University, Gazi University, Baskent University, Ege University, Medipol University, Gulhane Training and Research Hospital
- Study start
- 19 Apr 2018 (actual)
- Primary completion
- 19 Oct 2018 (actual)
- Study completion
- 19 Oct 2018 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients who had pelvic hemorrhage | – | Procedure: Stopping of pelvic bleeding via several surgical methodsPatients who had pelvic hemorrhage during complex abdomino-pelvic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Patients who had major pelvic bleeding during complex abdominopelvic surgery
- Patients operated in hospitals where over 225 colorectal cases were performed every year
Key exclusion criteria (1 listed)
- Patients operated for palliative intent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stopping of pelvic bleeding via several surgical methodsThose surgical methods were pelvic packing, electrocautery, energy devices, suturing, fastener, muscle welding, procoagulant chemicals, and combination of those | Procedure or surgery | Patients who had pelvic hemorrhage |
Primary outcome
Peri-operative outcomes
Time frame: Within postoperative day 30
Complication rate (Number of participants who had a complication divided by total number of participants)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pelvic Bleeding, run by Acibadem University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peri-operative outcomes (time frame: Within postoperative day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2020; AzTrials last refreshed its copy on 29 Oct 2026.