- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07377812
Predictors of Length of Stay and DAH30 After Elective Minimally Invasive Surgery in Older Adults (HOME-30)
Predictors of Length of Stay and Days Alive and at Home Within 30 Days (DAH30) After Elective Minimally Invasive Surgery in Older Adults: A Multicenter Retrospective Observational Study With International External Validation
This retrospective observational study aims to evaluate short-term postoperative outcomes in older adults undergoing elective minimally invasive surgery. The primary focus is on patient-centered recovery measures, including length of hospital stay and the number of days patients are alive and at home within 30 days after surgery.
Using routinely collected clinical data, the study will assess demographic, clinical, and perioperative factors associated with delayed discharge and reduced time spent at home after surgery. Understanding these factors may help clinicians and healthcare systems better plan postoperative care and optimize recovery pathways for older surgical patients.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a multicenter, retrospective, observational cohort study designed to identify predictors of short-term postoperative outcomes in older adults undergoing elective minimally invasive surgical procedures.
The study includes patients aged 70 years and older who underwent elective laparoscopic or minimally invasive abdominal surgery. All data are derived exclusively from routinely collected medical records generated during standard clinical care. No study-related interventions, changes in clinical management, or additional patient contacts are performed.
The primary outcomes of interest are length of hospital stay and days alive and at home within 30 days after surgery (HOME-30 / DAH30). Secondary analyses explore the association of demographic characteristics, comorbidities, perioperative factors, and discharge timing with these outcomes.
The study aims to improve understanding of non-medical contributors to prolonged hospitalization in older surgical patients and to support the development of patient-centered outcome measures applicable across different healthcare systems.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Moscow, Russia
- K+31 Clinic
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 70 years or older at the time of surgery
- Undergoing elective minimally invasive surgical procedures
- Surgery performed under general anesthesia
- Availability of complete medical records required to assess study outcomes
Exclusion Criteria:
- Emergency or urgent surgical procedures
- Open (non-minimally invasive) surgery
- Incomplete medical records precluding outcome assessment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Older Adults Undergoing Elective Minimally Invasive Surgery
This cohort includes adults aged 70 years and older who underwent elective minimally invasive surgical procedures.
The study is retrospective and observational in nature.
No interventions were assigned as part of the study; all analyses are based on routinely collected clinical data obtained during standard care.
|
This is a retrospective observational study.
No interventions were assigned or administered as part of the study.
All analyses are based on routinely collected clinical data obtained during standard clinical care.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Days Alive and at Home Within 30 Days After Surgery (DAH30)
Time Frame: Postoperative Day 0 through Postoperative Day 30
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Days Alive and at Home within 30 days after surgery (DAH30), defined as the total number of days during the first 30 days following the index surgical procedure that the patient is alive and not admitted to an acute care hospital.
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Postoperative Day 0 through Postoperative Day 30
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Length of Hospital Stay After Surgery
Time Frame: Perioperative period
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Length of hospital stay, defined as the number of days from the date of surgery to the date of discharge from the index hospitalization.
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Perioperative period
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All-Cause Hospital Readmission Within 30 Days After Surgery
Time Frame: Postoperative Day 1 through Postoperative Day 30
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Any unplanned hospital readmission for any cause occurring within 30 days after discharge from the index surgical hospitalization.
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Postoperative Day 1 through Postoperative Day 30
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Postoperative Complications Within 30 Days
Time Frame: Postoperative Day 0 through Postoperative Day 30
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Occurrence of postoperative complications within 30 days after surgery, classified according to the Clavien-Dindo grading system.
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Postoperative Day 0 through Postoperative Day 30
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Discharge Destination After Surgery
Time Frame: Perioperative period
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Discharge destination following index hospitalization, categorized as home, rehabilitation facility, skilled nursing facility, or other healthcare institution.
|
Perioperative period
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HOME30-RETRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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