Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery

Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study

Evaluation of preoperative physical capacity and its evolution in the postoperative period in older patients after undergoing laparoscopic surgery for colorectal cancer, with the test:

- Short Physical Performance Battery (SPPB)

After the inclusion of the first 10 patients, a preliminary feasibility study will be carried out and thus we have coverage of this pilot study.

Study Overview

• Status: Unknown
• Conditions: Colorectal Disorders
• Intervention / Treatment: Other: Perioperative assessment of physical capacity

• Study Type: Observational
• Enrollment (Anticipated): 39

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic colorectal surgery.

Description

Inclusion Criteria:

• Patients age ≥65 years.
• ASA I-III
• Patients with absence of cognitive deficit.
• Informed consent signed prior to surgery.

Exclusion Criteria:

• Refusal of the patient to participate in the study.
• Patients with disabilities to give their consent.
• ASA IV-V.
• Pregnancy or lactation.
• Health status that prevent physical exercise, such as unstable heart disease, severe systematic disease, or serious orthopedic conditions

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the physical capacity	Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire	21 days before surgery
Evaluation of the physical capacity	Evaluation of the physical capacity only with the Short Physical Performance	21 days after surgery

Collaborators and Investigators

• Sponsor: Hospital Universitario La Fe

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): June 1, 2020
• Study Completion (Anticipated): June 1, 2020

Study Registration Dates

• First Submitted: May 22, 2020
• First Submitted That Met QC Criteria: June 5, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): June 9, 2020
• Last Update Submitted That Met QC Criteria: June 5, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: ATLAS

Drug and device information, study documents

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