Modified Frailty Index for Minimally Invasive Distal Pancreatectomy

Postoperative Complication Clinical Trial

Official title:

Evaluation of Postoperative Outcomes of Minimally Invasive Distal Pancreatectomy for Left-sided Pancreatic Tumors Based on the Modified Frailty Index: A Retrospective Cohort Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05837793
• Other study ID #: 2022-1709
• Status: Completed
• Start date: January 1, 2023
• Est. completion date: April 10, 2023

Study information

• Verified date: April 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to investigate the difference in postoperative complications according to the modified Frailty Index (mFI) in patients who underwent minimally invasive distal pancreatectomy for pancreatic tumors at the Asan Medical Center's Department of Hepato-Biliary-Pancreatic Surgery from 2005 to 2019. It also seeks to confirm the utility of mFI as a predictive factor for postoperative complications in frail patients in the future.

Description:

Distal pancreatectomy is a surgery performed to treat tumors in the distal pancreas. The minimally invasive approach to this surgery has become the standard due to its shorter hospital stay, quicker recovery, less pain, and similar complication rates compared to open surgery, especially for benign tumors. In selected patients with malignant tumors, minimally invasive distal pancreatectomy has gradually expanded to a state where it is not inferior to open surgery in terms of postoperative complications and long-term prognosis. As the average lifespan increases, elderly patients with comorbidities are steadily increasing in numbers among those who undergo distal pancreatectomy. However, predicting postoperative complications and mortality rates for these patients is still difficult. Simple yet effective predictive factors for postoperative complications are needed. The Canadian Study of Health and Aging has created a standardized frailty index (CSHA-FI) as a tool for predicting frailty in elderly patients, and a modified Frailty Index (mFI) has been developed for easy use. The mFI has been reported as a predictor of postoperative morbidity and mortality rates after colorectal and vascular surgery. This study aims to investigate whether mFI can be used as a predictive factor for postoperative morbidity and mortality rates in patients who undergo minimally invasive distal pancreatectomy and to utilize it for clinical treatment in the future.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: April 10, 2023
• Est. primary completion date: April 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• The study population consists of patients who underwent minimally invasive distal pancreatectomy for pancreatic body or tail tumors between January 2005 and December 2019.

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Frailty
• Postoperative Complication
• Postoperative Complications

Intervention

Behavioral:
• Modified frailty index
The mFI includes the following 11 items from the National Surgical Quality Improvement Program (NSQIP): diabetes; functional status (not independent); chronic obstructive pulmonary disease (COPD) or pneumonia; congestive heart failure; history of myocardial infarction; hypertension requiring medication; peripheral vascular disease or rest pain; impaired sensorium; history of either transient ischemic attack or cerebrovascular accident; history of cerebrovascular accident with neurologic deficit; and prior percutaneous coronary intervention, previous coronary surgery, or history of angina.

Locations

Country	Name	City	State
Korea, Republic of	Asan medical center	Seoul	Republic Of Korea

Sponsors (1)

Lead Sponsor	Collaborator
Song Cheol Kim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative outcomes	Comparison of the Postoperative outcomes according to the mFI	6 months