- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05616403
Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy
Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study
Study Overview
Detailed Description
Laparoscopic pancreaticoduodenectomy (LPD) remains one of the most complex and technically challenging procedures in pancreatic surgery, although LPD has developed rapidly worldwide in recent years. Traditionally, quality assessment of LPD has mainly focused on individual outcome measures such as morbidity, mortality, operative time, operative blood transfusion, readmission rates and length of hospital stay. However, individual outcome parameters do not reflect the multiple facets of the whole surgical procedure and do not measure actual variations among different hospitals. In this context, several outcome experts have suggested that composite measures of surgical quality may be better than individual outcome parameters to compare hospital performance. Textbook outcome (TO) is such a composite outcome measure of multiple desirable outcome metrics, which was first proposed in 2013 by Dutch colorectal surgeons in order to give a comprehensive summary of hospital performance. TO is realized when all of the desired outcome parameters are achieved following surgery and represents the optimal ("textbook") hospitalization.
Although several studies on TO in pancreatic surgery have been reported, relevant data on LPD are lacking, especially from China. The objective of this study was to assess TO among patients undergoing LPD in China, identify factors independently associated with achieving TO and analyze hospital variations regarding the TO after case-mix adjustment.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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-
Hubei
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Wuhan, Hubei, China, 430030
- Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients underwent laparoscopic pancreaticoduodenectomy.
- Aged 18 to 75 years old.
Exclusion Criteria:
- Peritoneal seeding or metastasis to distant sites.
- Incomplete clinical data
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Textbook outcome group
Achieving textbook outcome after laparoscopic pancreaticoduodenectomy
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This is an observational study without any intervention
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Non-Textbook outcome group
Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy
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This is an observational study without any intervention
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Textbook outcome
Time Frame: up to 90 days
|
Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade ≥ Ⅲ), in-hospital or 30-day mortality, and readmission within 30 days after discharge.
|
up to 90 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Renyi Qin, MD, Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJDBPS13
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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