Health TrialsbyHealthPanel

Functional Capacity and Days Alive Out of Hospital at 30 Days

ConditionGastrointestinal Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University

About this trial

This prospective observational study aims to compare days alive and out of hospital at 30 days (DAOH-30) in patients with poor or good functional capacity undergoing gastrointestinal surgeries. The investigators are testing the hypothesis that patients with good functional capacity will have longer days alive and out of hospital than those with poor.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients undergoing intermediate and major upper or lower gastrointestinal surgeries (small intestine, colon, rectal, gastric, esophagus) with a predicted hospital stay of more than 24 hours

Patients aged 18 and above

Signed written informed consent

Reaching all perioperative data

Disqualifiers

Day case/ambulatory or one overnight hospital stay for minor gastrointestinal and perianal surgeries (hernia repair, hemorrhoidectomy, perianal abscess and fistula, appendectomy)

Hepatobiliary surgeries (hepatectomy, pancreas and gallbladder surgeries)

Patients aged below 18

Not signed written informed consent

Trial population

Patients undergoing gastrointestinal surgeries at Istanbul Medical Faculty in Istanbul-Turkey will be selected for the study population. Istanbul Medical Faculty is a tertiary center university hospital with approximately 25.000 surgeries annually.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • DASI questionnaire

    Other intervention

    All patients will answer the DASI questionnaire before surgery. According to their scores, they will be divided into two groups. A score of 34 and below will be considered poor, and above 34 will be considered to have good functional capacity.

Treatment groups

470 Participants
are divided into 2 treatment groups
Group A: Group DASI ≤ 341 intervention
Group B: Group DASI > 341 intervention

Trial outcomes

Primary outcomes

1

Days alive and out of hospital at 30 days (DAOH-30)

It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 30th postoperative day.

Time frame
30 days

Secondary outcomes

1

Days alive and out of hospital at 90 days (DAOH-90)

It is calculated using mortality, hospital length of stay, and readmissions between the date of the index surgery and the 90th postoperative day.

Time frame
90 days
2

Postoperative complications

Cardiovascular, pulmonary, renal, neurologic, surgical, infectious and wound complications

Time frame
30 days
3

The Postoperative Morbidity Survey (POMS) defined morbidity

Pulmonary, infectious, renal, gastrointestinal, cardiovascular, neurological, hematological, wound complications and pain will be examined according to POMS

Time frame
30 days
4

Mortality

In and out of hospital mortality

Time frame
30 days and 90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istanbul University

Lead sponsor

Source ClinicalTrials.gov
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