Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

Sponsor

Tongji Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT05616403

Collaborator

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

1,029

Enrollment

Location

131.9

Actual Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pancreatic Neoplasms	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 Design

Study Type:

Observational

Actual Enrollment :

1029 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Jan 18, 2010

Actual Primary Completion Date :

Aug 28, 2016

Actual Study Completion Date :

Jan 15, 2021

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

Peritoneal seeding or metastasis to distant sites.
Incomplete clinical data

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei	China	430030

Sponsors and Collaborators

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

Investigators

Study Director: Renyi Qin, MD, Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Renyi Qin, Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery, Tongji Hospital

ClinicalTrials.gov Identifier:

NCT05616403

Other Study ID Numbers:

TJDBPS13

First Posted:

Nov 15, 2022

Last Update Posted:

Nov 15, 2022

Last Verified:

Nov 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Renyi Qin, Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery, Tongji Hospital

textbook outcome

laparoscopic pancreaticoduodenectomy

composite outcome measure

hospital variation

Additional relevant MeSH terms:

Pancreatic Neoplasms

Study Results

No Results Posted as of Nov 15, 2022