NCT04420117

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
39

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2020

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 22, 2020

Completed
10 days until next milestone

Study Start

First participant enrolled

June 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 9, 2020

Completed
Last Updated

June 9, 2020

Status Verified

June 1, 2020

Enrollment Period

Same day

First QC Date

May 22, 2020

Last Update Submit

June 5, 2020

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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

Interventions

Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing laparoscopic colorectal surgery.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

May 22, 2020

First Posted

June 9, 2020

Study Start

June 1, 2020

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

June 9, 2020

Record last verified: 2020-06