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Completed

NCT Number: NCT05616403

Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430030, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients underwent laparoscopic pancreaticoduodenectomy.
  • Aged 18 to 75 years old.

Exclusion criteria

  • Peritoneal seeding or metastasis to distant sites.
  • Incomplete clinical data

Treatment and study plan

No intervention

Other

This is an observational study without any intervention

Primary outcomes

  1. Textbook outcome

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Collaborators

  • 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
  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  • West China Hospital
  • Zhejiang University

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2021
First posted
Nov 15, 2022
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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