Risk Factors for Achieving TO After LDPPHR-t

Completed

• Conditions: Pancreatic Neoplasm of Uncertain Behavior Head
• Interventions: Other: No intervention

• Registration Number: NCT05569343
• Lead Sponsor: Tongji Hospital

Brief Summary

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

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 Timeline

• Study Start: 2020-05-08
• Primary Completion: 2021-12-23
• Study Completion: 2022-04-16
• Status Verified: 2022-10
• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Study First Posted: 2022-10-06
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Textbook outcome group	No intervention	Not achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection
Textbook outcome group	No intervention	Achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection

Primary Outcome Measures

Name	Time	Method
postoperative complications	up to 90 days	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.

Secondary Outcome Measures

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

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