Effects of Preoperative Frailty on Postoperative Recovery

Effects of Preoperative Frailty Assessed by Short Physical Performance Battery (SPPB) on Short-term Postoperative Recovery Among Gastric Cancer Patients Undergoing Minimally Invasive Distal Gastrectomy

This study aims to evaluate frailty using Short Physical Performance Battery (SPPB) before surgery and find out how frailty affects short-term postoperative recovery after surgery using Quality of Recovery-15 (QOR-15) questionnaire in patients undergoing minimally invasive distal gastrectomy for early gastric cancer.

Study Overview

• Status: Not yet recruiting
• Conditions: Frailty
• Intervention / Treatment: Diagnostic test: SPPB

Detailed Description

As the elderly population increases, the evaluation and management of preoperative frailty is becoming important. In patients with frailty, exposure to external stress, such as surgery, can reduce physical function, increase postoperative complication, and raise the risk of death. This study aims to evaluate frailty using an automated device performing SPPB (Andantefit) and find out how frailty affects postoperative recovery.

• Study Type: Observational
• Enrollment (Estimated): 139

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery

Description

Inclusion Criteria:

• Patients over 70 years of age, undergoing minimal invasive (laparoscopic, robot-assisted) distal gastrectomy for early gastric cancer, who can assess short-term postoperative recovery

Exclusion Criteria:

• Patients who have a difficulty in communication
• Patients who have a major medical or mental disease that can affect treatment outcome
• Patients unsuitable for this clinical trail on the opinion of researcher

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients undergoing minimally invasive distal gastrectomy for early gastric cancer	Diagnostic test: SPPB; Short Physical Performance Battery using the automated device (Andantefit)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)	The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.	on postoperative day 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)	The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.	on postoperative day 1
Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)	The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.	on postoperative day 2

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative QoR-15K score	The minimum and maximum values of QoR-15K are 0 and 150, respectively. Higher scores mean better outcomes.	postoperative day 1, 2, 3
Pain score at rest / during ambulation	Measuring with 11-pointed numeric rating scale (NRS). The minimum and maximum values of NRS are 0 and 11, respectively. Higher score means a more severe pain.	postoperative day 1, 2, 3
Ambulation distance	Total ambulation distance for a day. Measured by pedometer	postoperative day 1, 2, 3
First gas out time	Measurement of the time until the first gas out after surgery	up to 1 week after surgery
Postoperative complication	Based on Clavien-Dindo classification, Grade I-V	up to 1 month after surgery
Hospital length of stay	Measurement of the time until discharge after surgery	at the day of discharge (up to 1 month after admission)

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): December 26, 2023
• Primary Completion (Estimated): December 25, 2024
• Study Completion (Estimated): December 25, 2024

Study Registration Dates

• First Submitted: November 5, 2023
• First Submitted That Met QC Criteria: December 28, 2023
• First Posted (Actual): December 29, 2023

Study Record Updates

• Last Update Posted (Actual): December 29, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Frailty
• Other Study ID Numbers: 2308-179-1462

Drug and device information, study documents

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