Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Other: No intervention

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: Observational
• Enrollment (Actual): 1029

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Textbook outcome group; Achieving textbook outcome after laparoscopic pancreaticoduodenectomy	Other: No intervention; This is an observational study without any intervention
Non-Textbook outcome group; Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy	Other: No intervention; This is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Textbook outcome	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: Tongji Hospital
• Collaborators: The First Affiliated Hospital with Nanjing Medical University; Guangdong Provincial Hospital of Traditional Chinese Medicine; Chinese PLA General Hospital; The Second Hospital of Hebei Medical University; West China Hospital; Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University; The First Hospital of Jilin University; Hunan Provincial People's Hospital; Wuhan Union Hospital, China; Fujian Medical University Union Hospital; Zhejiang University; Sir Run Run Shaw Hospital; Nanjing Medical University; First Affiliated Hospital of Chongqing Medical University; The Affiliated Hospital of Xuzhou Medical University; Huadong Hospital
• Investigators: Study Director: Renyi Qin, MD, Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2010
• Primary Completion (Actual): August 28, 2016
• Study Completion (Actual): January 15, 2021

Study Registration Dates

• First Submitted: November 8, 2022
• First Submitted That Met QC Criteria: November 8, 2022
• First Posted (Actual): November 15, 2022

Study Record Updates

• Last Update Posted (Actual): November 15, 2022
• Last Update Submitted That Met QC Criteria: November 8, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: hospital variation; textbook outcome; laparoscopic pancreaticoduodenectomy; composite outcome measure
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: TJDBPS13

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No