Clinical trial NCT05616403: Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy
Official title: Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy: a Retrospective, Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Keywords: textbook outcome
laparoscopic pancreaticoduodenectomy
composite outcome measure
hospital variation
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: The Second Hospital of Hebei Medical University
name: Hunan Provincial People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
name: Chinese PLA General Hospital
name: Sir Run Run Shaw Hospital
name: The Affiliated Hospital of Xuzhou Medical University
name: Wuhan Union Hospital, China
name: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
name: First Affiliated Hospital of Chongqing Medical University
name: Fujian Medical University Union Hospital
name: The First Affiliated Hospital with Nanjing Medical University
name: Nanjing Medical University
name: The First Hospital of Jilin University
name: Zhejiang University
name: Huadong Hospital
First posted: 2022-11-15
Enrollment: 1029
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients underwent laparoscopic pancreaticoduodenectomy from 16 high-volume pancreatic centers in China from January 2010 and August 2016.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Textbook outcome
timeFrame: up to 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital
name: Renyi Qin, MD
role: STUDY_DIRECTOR
References: