Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

Pancreatic Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05616403
• Other study ID #: TJDBPS13
• Status: Completed
• Start date: January 18, 2010
• Est. completion date: January 15, 2021

Study information

• Verified date: November 2022
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1029
• Est. completion date: January 15, 2021
• Est. primary completion date: August 28, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

Other:
• No intervention
This is an observational study without any intervention

Locations

Country	Name	City	State
China	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (17)

Lead Sponsor

Collaborator

Tongji Hospital

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Textbook outcome	Textbook outcome was defined as the absence of postoperative pancreatic fistula, postpancreatectomy hemorrhage, bile leakage, severe complications (Clavien-Dindo grade = ?), in-hospital or 30-day mortality, and readmission within 30 days after discharge.	up to 90 days