Textbook Outcome as a Composite Outcome Measure in Laparoscopic Pancreaticoduodenectomy

NCT05616403 | Completed

• 1 other identifier: TJDBPS13
• Study Type: observational
• Target: 1,029
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatic Neoplasms

Keywords

textbook outcome; laparoscopic pancreaticoduodenectomy; composite outcome measure; hospital variation

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Textbook outcome group

Achieving textbook outcome after laparoscopic pancreaticoduodenectomy

Other: No intervention

Non-Textbook outcome group

Not achieving textbook outcome after laparoscopic pancreaticoduodenectomy

Other: No intervention

Interventions

No intervention OTHER

This is an observational study without any intervention

Non-Textbook outcome group; Textbook outcome group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Wuhan, Hubei, 430030, China

Location

Related Publications (1)

• Wu Y, Peng B, Liu J, Yin X, Tan Z, Liu R, Hong D, Zhao W, Wu H, Chen R, Li D, Huang H, Miao Y, Liu Y, Liang T, Wang W, Yuan J, Li S, Zhang H, Wang M, Qin R; Minimally Invasive Treatment Group in the Pancreatic DiseaseBranch of China's International Exchange and Promotion Association for Medicine and Healthcare (MITG-P-CPAM). Textbook outcome as a composite outcome measure in laparoscopic pancreaticoduodenectomy: a multicenter retrospective cohort study. Int J Surg. 2023 Mar 1;109(3):374-382. doi: 10.1097/JS9.0000000000000303.

  PMID: 36912568 DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Officials

• Renyi Qin, MD

  Department of Biliary-Pancreatic Surgery, Affiliated Tongji Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Surgery, Chief Physician, Director of Surgical Supervision Department, Deputy Director of Institute of Hepatobiliary&Pancreatic, Director of Department of Biliary-Pancreatic Surgery

Study Record Dates

• First Submitted: November 8, 2022
• First Posted: November 15, 2022
• Study Start: January 18, 2010
• Primary Completion: August 28, 2016
• Study Completion: January 15, 2021
• Last Updated: November 15, 2022

Record last verified: 2022-11

Locations

CN (1)