ColectomyNCT00888888
Colonic Resections in Patients With Suspected Appendicitis
An observational study of Colectomy and Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
Trial summary
Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Colectomy, Appendicitis
- What is being tested?
- Right hemicolectomy with or without primary anastomosis
- Type of treatment
- Surgery or procedure
- How many people
- 87 participants
- Where
- 1 siteChile
- Study dates
- Apr 2009to Jun 2010
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients submitted to appendectomy for suspected acute appendicitis and in whom the surgeon takes the decision to convert to right colectomy based on operative findings and other factors the we aim to identify
Who may be able to join
- Patients older than 15 years of age
- Male or female
- Suspected of having acute appendicitis
- Converted to right hemicolectomy
Who cannot join
- Patients in whom a right hemicolectomy was planned initially
- Right hemicolectomy for causes other than suspected acute appendicitis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Risk Factors for Colonic Resections in Patients With Suspected Acute Appendicitis
Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection.
The investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.
- Conditions
- Colectomy, Appendicitis
- Being tested
- Right hemicolectomy with or without primary anastomosis
- Keywords
- Acute appendicitis, Colonic diverticulitis, Colonic tumors, Colonic resections
- Medical subject headings
- Appendicitis, Diverticulitis, Colonic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Right hemicolectomy with or without primary anastomosisProcedure or surgery
During open classic appendectomy (McBurney incision) the surgeon decided to convert to midline extended laparotomy to perform a right hemicolectomy
| Study group | Role | What they receive |
|---|---|---|
| Cohort: Patients with colonic resections | Colonic resections in patients submitted to appendicectomy for suspected acute appendicitis Receives: Procedure: Right hemicolectomy with or without primary anastomosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-term survival
Measured: 3 months
Secondary outcomes (1)
Long-term survival
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionJun 2010
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColectomyStudies 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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cirujanos la Serena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MARCELO A. BELTRAN, M.D., Cirujanos la Serena
- Investigators
- MARCELO A BELTRAN, M.D., Principal investigator, Hospital de La Serena
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888888
- Sponsor's protocol ID
- HLS-2604009-01
- Status last verified
- Oct 2012
- First submitted
- 27 Apr 2009
- Last updated
- 31 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Factors for Colonic Resections in Patients With Suspected Acute Appendicitis
- ClinicalTrials.gov ID
- NCT00888888
- Acronym / sponsor ID
- HLS-2604009-01
- Conditions
- Colectomy, Appendicitis
- Keywords
- Acute appendicitis, Colonic diverticulitis, Colonic tumors, Colonic resections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Cirujanos la SerenaUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Jun 2010 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 28 Apr 2009 (estimated)
- 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.
Although many reports have been published on colonic resections in patients with suspected appendicitis and the diseases that cause the decision to resect the colon have been identified and their proper treatments have been established, there is no report on the risk factors present in converting a simple appendectomy into a major colonic resection.
The investigators aimed to identify the risk factors that lead the surgeon to perform a colonic resection in patients undergoing surgery for initially suspected acute appendicitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort: Patients with colonic resections | – | Procedure: Right hemicolectomy with or without primary anastomosisColonic resections in patients submitted to appendicectomy for suspected acute appendicitis |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients submitted to appendectomy for suspected acute appendicitis and in whom the surgeon takes the decision to convert to right colectomy based on operative findings and other factors the we aim to identify
Key inclusion criteria (4 listed)
- Patients older than 15 years of age
- Male or female
- Suspected of having acute appendicitis
- Converted to right hemicolectomy
Key exclusion criteria (2 listed)
- Patients in whom a right hemicolectomy was planned initially
- Right hemicolectomy for causes other than suspected acute appendicitis
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 |
|---|---|---|
| Right hemicolectomy with or without primary anastomosisDuring open classic appendectomy (McBurney incision) the surgeon decided to convert to midline extended laparotomy to perform a right hemicolectomy | Procedure or surgery | Cohort: Patients with colonic resections |
Primary outcome
Short-term survival
Time frame: 3 months
1 secondary outcome
Long-term survival
Time frame: 5 years
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 31 Oct 2012.
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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.
MARCELO A BELTRAN, M.D. principal investigator
Hospital de La Serena
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 Colectomy and Appendicitis, run by Cirujanos la Serena at 1 site in Chile.
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 2 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 31 Oct 2012. 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 Chile. 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?
Short-term survival (time frame: 3 months). 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 31 Oct 2012.