Risk Factors for Achieving TO After LDPPHR-t

Risk Factors for Achieving Textbook Outcome After Laparoscopic Duodenum-preserving Total Pancreatic Head Resection: a Retrospective, Observational Study

This is a single, retrospective, observational study to investigate the risk factors for achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasm of Uncertain Behavior Head
• Intervention / Treatment: Other: No intervention

Detailed Description

Increasing numbers of benign or low-grade malignant neoplasms at the head of pancreas are being diagnosed due to computed tomography (CT), magnetic resonance imaging (MRI) and endoscopic ultrasonography (EUS). Laparoscopic duodenum-preserving total pancreatic head resection (LDPPHR-t) has been accepted as a valid alternative treatment for benign and low-grade malignant neoplasms at the head of the pancreas. The evaluation of quality of LDPPHR-t is important for surgeons to improve surgical quality. Currently, the evaluation of surgical quality mainly depends on some single outcome indicators, such as morbidity, mortality, readmission rate, or hospital stay. These single outcome indicators are difficult to accurately reflect the overall surgical quality and the composite outcome measures may be better than single outcome indicators. Textbook outcome (TO) is such a composite concept and is realized when all the requirements after operation are achieved according to the "all or none" principle. TO reflects the ideal surgical outcome and is a multidimensional measure for surgical quality assurance. However, the risk factors for achieving TO after LDPPHR-t is unknown and no relevant articles have been reported so far. The objective of study was to identify the risk factors for achieving TO after LDPPHR-t.

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Department of Biliary and Pancreatic Surgery, Tongji Hospital, Affiliated Tongji Medical College, Huazhong University of Science and Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients underwent laparoscopic duodenum-preserving total pancreatic head resection in the department of Biliary-Pancreatic Surgery of Tongji Hospital from May 2020 to December 2021.

Description

Inclusion Criteria:

1. Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
2. Aged 18 to 75 years old.

Exclusion Criteria:

1. Peritoneal seeding or metastasis to distant sites.
2. Incomplete clinical data.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Textbook outcome group; Achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection	Other: No intervention; This is an observational study without any intervention
Non-Textbook outcome group; Not achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection	Other: No intervention; This is an observational study without any intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative complications	The postoperative complications were graded into mild complications and severe complications according to the Clavien-Dindo classification of surgical complications, including postpancreatectomy hemorrhage, postoperative pancreatic fistula , and bile leakage.	up to 90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation time	Operation time defined as the time from skin incision or trocar placement to complete skin closure	Intraoperative
Intraoperative blood loss	Intraoperative blood loss recorded by the anesthetist using a vacuum system	Intraoperative
Readmission	Readmission defined as any readmission within 30 days after discharge	up to 30 days

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Actual): December 23, 2021
• Study Completion (Actual): April 16, 2022

Study Registration Dates

• First Submitted: October 3, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 6, 2022

Study Record Updates

• Last Update Posted (Actual): October 6, 2022
• Last Update Submitted That Met QC Criteria: October 4, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Risk factors; Laparoscopic; Textbook outcome; Endoscopic nasobiliary drainage; Total pancreatic head resection; Duodenum-preserving
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: TJDBPS12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No