Colorectal DisordersNCT04420117
Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery
An observational study of Colorectal Disorders, run by Hospital Universitario La Fe.
Trial 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… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Colorectal Disorders
- What is being tested?
- Perioperative assessment of physical capacity
- How many people
- 39 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2020to 1 Jun 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients undergoing laparoscopic colorectal surgery.
Who may be able to join
- Patients age ≥65 years.
- ASA I-III
- Patients with absence of cognitive deficit.
- Informed consent signed prior to surgery.
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Colorectal Disorders
- Being tested
- Perioperative assessment of physical capacity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perioperative assessment of physical capacityOther
Evaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the physical capacity
Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire
Measured: 21 days before surgery
Evaluation of the physical capacity
Evaluation of the physical capacity only with the Short Physical Performance
Measured: 21 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020 (estimated)
- Primary completion1 Jun 2020 (estimated)
- Study completion1 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oscar Diaz-Cambronero, Hospital Universitario La Fe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420117
- Sponsor's protocol ID
- Atlas
- Status last verified
- Jun 2020
- First submitted
- 22 May 2020
- Last updated
- 9 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Assessment of Physical Capacity in Elderly Patients Undergoing Laparoscopic Colorectal Surgery- Atlas Study
- ClinicalTrials.gov ID
- NCT04420117
- Acronym / sponsor ID
- Atlas
- Conditions
- Colorectal Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- Hospital Universitario La FeUniversity, hospital or other
- Study start
- 1 Jun 2020 (estimated)
- Primary completion
- 1 Jun 2020 (estimated)
- Study completion
- 1 Jun 2020 (estimated)
- First posted
- 9 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients undergoing laparoscopic colorectal surgery.
Key inclusion criteria (4 listed)
- Patients age ≥65 years.
- ASA I-III
- Patients with absence of cognitive deficit.
- Informed consent signed prior to surgery.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perioperative assessment of physical capacityEvaluation of physical capacity with the Short Physical Performance Battery (SPPB) questionaire | Other | – |
Primary outcome
Evaluation of the physical capacity
Time frame: 21 days before surgery
Evaluation of the physical capacity only with the Short Physical Performance Battery (SPPB) questionnaire
Evaluation of the physical capacity
Time frame: 21 days after surgery
Evaluation of the physical capacity only with the Short Physical Performance
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Disorders, run by Hospital Universitario La Fe.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the physical capacity (time frame: 21 days before surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jun 2020.