2020-05-08
2021-12-23
2022-04-16
31
NCT05569343
Tongji Hospital
Tongji Hospital
OBSERVATIONAL
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.
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 Ȫll 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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2022-10-03 | N/A | 2022-10-04 |
2022-10-04 | N/A | 2022-10-06 |
2022-10-06 | N/A | 2022-10 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
N/A
Allocation:
N/A
Interventional Model:
N/A
Masking:
N/A
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| : Textbook outcome group Achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection | OTHER: No intervention
|
| : Non-Textbook outcome group Not achieving textbook outcome after laparoscopic duodenum-preserving total pancreatic head resection | OTHER: No intervention
|
| Primary Outcome Measures | 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 | 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 |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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