Emergency Colorectal Surgery in Ultra 80 PatientsNCT05443386
Colorectal Emergencies in Elderly Patients.
An observational study of Emergency Colorectal Surgery in Ultra 80 Patients, run by University of Foggia at 1 site in Italy.
Trial summary
Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Emergency Colorectal Surgery in Ultra 80 Patients
- What is being tested?
- colorectal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 32 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2020to 15 Jun 2022
- 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 80 years and older
- All sexes
- Older adult
Study population: patients older than 80 undergoing emergency surgery (within 24 hours) due to colon diseases were included in this retrospective study
Who may be able to join
- age older than eighty
- emergency conditions
Who cannot join
- trauma cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Emergency Surgery for Colon Diseases in Elderly Patients. Analysis of Complications, and Postoperative Course
Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. The aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term.
From November 2020 to February 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. We have collected and analysed all demographic, and operative data and then applied CR-POSSUM score and correlated with postoperative hospital stay and the onset of postoperative complications according to Clavien Dindo classification.
Read more
Postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. There was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. The number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. The value of Operative Severity Score in the Bowel Perforations, was significantly higher.
The use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. The CR-POSSUM score was important for predicting morbidity in our study. Emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.
- Being tested
- colorectal surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
colorectal surgeryProcedure or surgery
we have included several types of colorectal surgery procedures, in emergency conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative hospital stay
Measured: 30 days
Secondary outcomes (1)
postoperative complications
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start1 Oct 2020
- Primary completion20 Feb 2022
- Study completion15 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emergency Colorectal Surgery in Ultra 80 PatientsStudies 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
- Retrospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Foggia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mario Pacilli, University of Foggia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05443386
- Sponsor's protocol ID
- UFoggia1
- Status last verified
- Jul 2022
- First submitted
- 29 Jun 2022
- Last updated
- 25 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Emergency Surgery for Colon Diseases in Elderly Patients. Analysis of Complications, and Postoperative Course
- ClinicalTrials.gov ID
- NCT05443386
- Acronym / sponsor ID
- UFoggia1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University of FoggiaUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 20 Feb 2022 (actual)
- Study completion
- 15 Jun 2022 (actual)
- First posted
- 5 Jul 2022 (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.
Colon diseases can turn in a clinical emergency with the onset of some important complications. Some critical conditions are more common in aged patients because they are more frails. The aim of this study is to examine ultra 80 patients, undergoing emergency colorectal surgery, evaluating the aspects associated with post-operative complications and other problems in the short term.
From November 2020 to February 2022 we have included 32 consecutive patients older than 80 undergoing emergency surgery due to colon diseases. We have collected and analysed all demographic, and operative data and then applied CR-POSSUM score and correlated with postoperative hospital stay and the onset of postoperative complications according to Clavien Dindo classification.
Postoperative factors were selectively evaluated based on the clinical scenario and different colic pathologies. There was no statistically significant differences, in terms of postoperative hospital stay, postoperative complications, reoperation rate and 30-day mortality. The number of cases of blood transfusions was significant, more numerous in case of intestinal perforation and bleeding cases. The value of Operative Severity Score in the Bowel Perforations, was significantly higher.
The use of a score to stratify the risk is a useful tool especially in elderly patients to undergo emergency surgery. The CR-POSSUM score was important for predicting morbidity in our study. Emergency manifestations of colon diseases in the elderly show higher morbidity and mortality rates.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- patients older than 80 undergoing emergency surgery (within 24 hours) due to colon diseases were included in this retrospective study
Key inclusion criteria (2 listed)
- age older than eighty
- emergency conditions
Key exclusion criteria (1 listed)
- trauma cases
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 |
|---|---|---|
| colorectal surgerywe have included several types of colorectal surgery procedures, in emergency conditions | Procedure or surgery | – |
Primary outcome
postoperative hospital stay
Time frame: 30 days
1 secondary outcome
postoperative complications
Time frame: 30 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2022.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Colorectal Surgery in Ultra 80 Patients, run by University of Foggia at 1 site in Italy.
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 2 inclusion and 1 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: finished, as of the sponsor's last update on 25 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
postoperative hospital stay (time frame: 30 days). 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 25 Jul 2022.