Surgery--ComplicationsNCT05373238
Same Day Discharge After Laparoscopic Hysterectomy
An observational study of Surgery--Complications, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
Patients who are scheduled for laparoscopic hysterectomy will be included in the study. After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further. Read more about this study
- Who is it for?
- Ages 35 to 80 years, women only
- Conditions the study is for
- Surgery--Complications
- What is being tested?
- Early discharge
- Type of treatment
- Surgery or procedure
- How many people
- 194 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 30 Apr 2022
- 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 35 to 80 years
- Women only
- Adult, Older adult
Study population: Female patients aged 35-80 scheduled for laparoscopic hysterectomy
Who may be able to join
- Patients Scheduled For Hysterectomy
Who cannot join
- Diagnosis of Malignancy
- Those with intraoperative complication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Same Day Discharge After Laparoscopic Hysterectomy vs Late Discharge
Patients who are scheduled for laparoscopic hysterectomy will be included in the study.
After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further.
Our aim is to compare these two groups in terms of early complications and operation characteristics.
- Conditions
- Surgery--Complications
- Being tested
- Early discharge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early dischargeProcedure or surgery
Early discharge
| Study group | Role | What they receive |
|---|---|---|
| Early Discharge | < discharge before 24 hours Receives: Procedure: Early discharge | |
| Late Discharge | discharge after 24 hours Receives: Procedure: Early discharge |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complication in 30 days
Number of patients with surgical complications, postoperative complications, wound complications
Measured: 30 days
Secondary outcomes (2)
Postop hb
Number of patients whose hemoglobin value declined beyond two parameters. (mg/dL)
Measured: 30 day
Postop htc
Number of patients whose hematocrit value declined more than 5 percent (%)
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2022
- Study start15 Oct 2021
- Primary completion30 Apr 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery--ComplicationsStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Caglar Cetin, Bezmialem Vakif University
- Investigators
- Gurkan Kiran, Study chair, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05373238
- Sponsor's protocol ID
- BVU-10.2021
- Status last verified
- Oct 2022
- First submitted
- 5 May 2022
- Last updated
- 12 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Same Day Discharge After Laparoscopic Hysterectomy vs Late Discharge
- ClinicalTrials.gov ID
- NCT05373238
- Acronym / sponsor ID
- BVU-10.2021
- Conditions
- Surgery--Complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 30 Apr 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 13 May 2022 (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.
Patients who are scheduled for laparoscopic hysterectomy will be included in the study.
After the operation, those who are well and without major distress will be discharged from the hospital before 24 hours. Those who have pain or have additional health problems will be observed further.
Our aim is to compare these two groups in terms of early complications and operation characteristics.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Discharge | – | Procedure: Early discharge< discharge before 24 hours |
| Late Discharge | – | Procedure: Early dischargedischarge after 24 hours |
Who may qualify
- Ages
- 35 to 80 years
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Female patients aged 35-80 scheduled for laparoscopic hysterectomy
Key inclusion criteria (1 listed)
- Patients Scheduled For Hysterectomy
Key exclusion criteria (2 listed)
- Diagnosis of Malignancy
- Those with intraoperative complication
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 |
|---|---|---|
| Early dischargeEarly discharge | Procedure or surgery | Early Discharge, Late Discharge |
Primary outcome
Complication in 30 days
Time frame: 30 days
Number of patients with surgical complications, postoperative complications, wound complications
2 secondary outcomes
Postop hb
Time frame: 30 day
Postop htc
Time frame: 30 day
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 12 Oct 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Surgery--Complications
Recruiting
Supervised Endoscopic Tele-controlled Intelligent Lithotripsy
Renal Stone
Enrolling by invitation
Use of Tracking Devices to Locate Abnormalities During Invasive Procedures
Adenocarcinoma, Prostate Neoplasms
Not yet recruitingObservational study
Hugo™ RAS Urology Post-Market Clinical Study
Prostatectomy, Cystectomy
Recruiting
Processed Electroencephalography-guided General Anesthesia and Outcomes in Major Abdominal Surgery
Postoperative Acute Kidney Injury
Not yet recruitingObservational study
Biomarkers of Postoperative Complications After Cardiac Surgery
Postoperative Complications
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.
Gurkan Kiran study chair
Bezmialem Vakif University
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 Surgery--Complications, run by Bezmialem Vakif 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 1 inclusion and 2 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 12 Oct 2022. 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?
Complication in 30 days (time frame: 30 days). 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 12 Oct 2022.