Effects of Preoperative Frailty on Postoperative Recovery

NCT06185270 | Unknown

• 1 other identifier: 2308-179-1462
• Study Type: observational
• Target: 139
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Frailty

Outcome Measures

Primary Outcomes (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 3

Secondary Outcomes (2)

• Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)

  on postoperative day 1

• Poor postoperative outcome (the Korean version of Quality of Recovery-15 [QoR-15K] < 122)

  on postoperative day 2

Other Outcomes (6)

• Postoperative QoR-15K score

  postoperative day 1, 2, 3

• Pain score at rest / during ambulation

  postoperative day 1, 2, 3

• Ambulation distance

  postoperative day 1, 2, 3

Study Arms (1)

Patients undergoing minimally invasive distal gastrectomy for early gastric cancer

Diagnostic Test: SPPB

Interventions

SPPB DIAGNOSTIC_TEST

Short Physical Performance Battery using the automated device (Andantefit)

Patients undergoing minimally invasive distal gastrectomy for early gastric cancer

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2023
• First Posted: December 29, 2023
• Study Start: December 26, 2023
• Primary Completion: December 25, 2024
• Study Completion: December 25, 2024
• Last Updated: December 29, 2023

Record last verified: 2023-11