Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Other: No intervention

• Registration Number: NCT05616403
• Lead Sponsor: Tongji Hospital

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.

Study Timeline

• Study Start: 2010-01-18
• Primary Completion: 2016-08-28
• Study Completion: 2021-01-15
• Status Verified: 2022-11
• Study First Submitted: 2022-11-08
• Study First Submitted QC: 2022-11-08
• Last Update Submitted: 2022-11-08
• Study First Posted: 2022-11-15
• Last Update Posted: 2022-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1029

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Textbook outcome group	No intervention	Achieving textbook outcome after laparoscopic pancreaticoduodenectomy
Non-Textbook outcome group	No intervention	Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy

Primary Outcome Measures

Name	Time	Method
Textbook outcome	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.

Trial Locations

Locations (1)

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China