Effects of Preoperative Frailty on Postoperative Recovery

Frailty Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06185270
• Other study ID #: 2308-179-1462
• Status: Not yet recruiting
• Start date: December 26, 2023
• Est. completion date: December 25, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 139
• Est. completion date: December 25, 2024
• Est. primary completion date: December 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Frailty

Intervention

Diagnostic Test:
• SPPB
Short Physical Performance Battery using the automated device (Andantefit)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	Ambulation distance	Total ambulation distance for a day. Measured by pedometer	postoperative day 1, 2, 3
Other	First gas out time	Measurement of the time until the first gas out after surgery	up to 1 week after surgery
Other	Postoperative complication	Based on Clavien-Dindo classification, Grade I-V	up to 1 month after surgery
Other	Hospital length of stay	Measurement of the time until discharge after surgery	at the day of discharge (up to 1 month after admission)
Primary	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	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
Secondary	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