Urological InjuryNCT04042129
Urological Complications and Management After Gynecological Operations
An observational study of Urological Injury and Gynecologic Disease, run by Acibadem University.
Trial summary
OBJECTIVE: In the study, investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Urological Injury, Gynecologic Disease
- What is being tested?
- gynecologic operations with urological complications
- How many people
- 1,754 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jan 2019
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: gynecologic operations with urologic complications Patients' previous medical records, detailed physical examination findings, age, menopausal status, American Society of Anesthesiologists Classification (ASA) scores, and body mass indexes (BMI) were noted. Also, preoperative hemoglobin levels, postoperative hemoglobin levels, and hospitalization durations were recorded. In addition, indications for gynecologic surgery, sites of injury and management modalities of injury were recorded
Who may be able to join
- -Gynecologic operations with urologic complications
Who cannot join
- Patients with incomplete data and patients who underwent obstetric operations
- patients aged under 18
- patients who were operated under emergency conditions
About this study
OBJECTIVE: In the study, investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.
METHODS: The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.
Read the detailed description
In women, the anatomical localization of urinary and genital tracts is very close to each other. This proximity can lead to injuries during pelvic operations. Advances in gynecologic operation techniques and the growing experience of gynecologists may suggest a decrease in urological injuries. However, according to the literature, gynecologists face approximately 0.2% to 1% urinary tract injuries during pelvic surgeries. The increase in the number of recurrent surgeries and adverse situations encountered during the operations such as adhesions and anatomical variations factor into the persistence of urologic complications. Investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.
The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.
- Conditions
- Urological Injury, Gynecologic Disease
- Being tested
- gynecologic operations with urological complications
- Medical subject headings
- Genital Diseases, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gynecologic operations with urological complicationsOther
| Study group | Role | What they receive |
|---|---|---|
| 1 | gynecologic operations with urologic complications Receives: Other: gynecologic operations with urological complications |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and type of Urological Complications and Management After Gynecological Operations
Measured: retrospective 3 years period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2019
- Study startJan 2016
- Primary completionJan 2019
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urological InjuryStudies of the same condition, open and under way.
- More trials run by Acibadem UniversityThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,754 participants (actual)
Sponsor and investigators
- Lead sponsor
- Acibadem University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04042129
- Sponsor's protocol ID
- AcibademUr
- Status last verified
- Jul 2019
- First submitted
- 6 Jul 2019
- Last updated
- 1 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urological Complications and Management After Gynecological Operations
- ClinicalTrials.gov ID
- NCT04042129
- Acronym / sponsor ID
- AcibademUr
- Conditions
- Urological Injury, Gynecologic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,754 participants (actual)
- Lead sponsor
- Acibadem UniversityUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Jan 2019 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 1 Aug 2019 (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.
OBJECTIVE: In the study, investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.
METHODS: The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.
Detailed description
In women, the anatomical localization of urinary and genital tracts is very close to each other. This proximity can lead to injuries during pelvic operations. Advances in gynecologic operation techniques and the growing experience of gynecologists may suggest a decrease in urological injuries. However, according to the literature, gynecologists face approximately 0.2% to 1% urinary tract injuries during pelvic surgeries. The increase in the number of recurrent surgeries and adverse situations encountered during the operations such as adhesions and anatomical variations factor into the persistence of urologic complications. Investigators aimed to evaluate the urological complications of gynecologic operations in a tertiary academic center and to evaluate the treatment methods of these complications.
The files of all patients who underwent gynecological surgery between January 2016 and January 2019 were retrospectively reviewed. The age of patients with urological complications, American Anesthesia Society score, menopausal status, body mass index (BMI), preoperative hemoglobin level, postoperative hemoglobin level and hospitalization duration and number of previous surgeries were recorded. In addition, the patients with urological complications were evaluated in terms of the indications for surgery, type of surgery, type of urological complication and the way of treatment of the complication.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: gynecologic operations with urological complicationsgynecologic operations with urologic complications |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- gynecologic operations with urologic complications Patients' previous medical records, detailed physical examination findings, age, menopausal status, American Society of Anesthesiologists Classification (ASA) scores, and body mass indexes (BMI) were noted. Also, preoperative hemoglobin levels, postoperative hemoglobin levels, and hospitalization durations were recorded. In addition, indications for gynecologic surgery, sites of injury and management modalities of injury were recorded
Key inclusion criteria (1 listed)
- -Gynecologic operations with urologic complications
Key exclusion criteria (3 listed)
- Patients with incomplete data and patients who underwent obstetric operations
- patients aged under 18
- patients who were operated under emergency conditions
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 |
|---|---|---|
| gynecologic operations with urological complications | Other | 1 |
Primary outcome
Number and type of Urological Complications and Management After Gynecological Operations
Time frame: retrospective 3 years period
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 1 Aug 2019.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Urological Injury and Gynecologic Disease, run by Acibadem University.
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 1 inclusion and 3 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 1 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Number and type of Urological Complications and Management After Gynecological Operations (time frame: retrospective 3 years period). 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 1 Aug 2019.