Colorectal Disorders Clinical Trial
Official title:
Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study
| NCT number | NCT04420117 |
| Other study ID # | Atlas |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | June 1, 2020 |
| Est. completion date | June 1, 2020 |
| Verified date | June 2020 |
| Source | Hospital Universitario La Fe |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Not yet recruiting |
| Enrollment | 39 |
| Est. completion date | June 1, 2020 |
| Est. primary completion date | June 1, 2020 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 65 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hospital Universitario La Fe |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Evaluation of the physical capacity | Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire | 21 days before surgery | |
| Primary | Evaluation of the physical capacity | Evaluation of the physical capacity only with the Short Physical Performance | 21 days after surgery |
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