Completed

NCT Number: NCT05569343

Risk Factors for Achieving TO After LDPPHR-t

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

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Key information

Conditions

Pancreatic Neoplasm of Uncertain Behavior Head

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

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.

Who can participate

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

Inclusion criteria

Patients underwent laparoscopic duodenum-preserving total pancreatic head resection.
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

postoperative complications

Time frame: 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 outcomes

Operation time

Time frame: Intraoperative

Operation time defined as the time from skin incision or trocar placement to complete skin closure
Intraoperative blood loss

Time frame: Intraoperative

Intraoperative blood loss recorded by the anesthetist using a vacuum system
Readmission

Time frame: up to 30 days

Readmission defined as any readmission within 30 days after discharge

Sponsors and collaborators

Lead sponsor

Tongji Hospital

Other

Registry information

Official study title

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

Important dates

Study start: 2020
Primary completion: 2021
Study completion: 2022
First posted: Oct 6, 2022
Registry last updated: Oct 6, 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.