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Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05616403
Enrollment
1029
Registered
2022-11-15
Start date
2010-01-18
Completion date
2021-01-15
Last updated
2022-11-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

textbook outcome, laparoscopic pancreaticoduodenectomy, composite outcome measure, hospital variation

Brief summary

This is a multicenter, retrospective, observational study. Textbook outcome is a composite outcome measure for surgical quality assessment. The aim of this study was to assess textbook outcome following laparoscopic pancreaticoduodenectomy in China, identify factors independently associated with achieving textbook outcome and analyze hospital variations regarding the textbook outcome after case-mix adjustment.

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.

Interventions

OTHERNo intervention

This is an observational study without any intervention

Sponsors

West China Hospital
CollaboratorOTHER
The Second Hospital of Hebei Medical University
CollaboratorOTHER
Hunan Provincial People's Hospital
CollaboratorOTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
CollaboratorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
Sir Run Run Shaw Hospital
CollaboratorOTHER
The Affiliated Hospital of Xuzhou Medical University
CollaboratorOTHER
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
CollaboratorOTHER
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
CollaboratorOTHER
First Affiliated Hospital of Chongqing Medical University
CollaboratorOTHER
Fujian Medical University Union Hospital
CollaboratorOTHER
The First Affiliated Hospital with Nanjing Medical University
CollaboratorOTHER
Nanjing Medical University
CollaboratorOTHER
The First Hospital of Jilin University
CollaboratorOTHER
Zhejiang University
CollaboratorOTHER
Huadong Hospital
CollaboratorOTHER
Tongji Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

1. Patients underwent laparoscopic pancreaticoduodenectomy. 2. Aged 18 to 75 years old.

Exclusion criteria

1. Peritoneal seeding or metastasis to distant sites. 2. Incomplete clinical data

Design outcomes

Primary

MeasureTime frameDescription
Textbook outcomeup to 90 daysTextbook 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026