Colostomy StomaNCT05635188
Impact of Surgical Technique on Post-operative Complications in Urgency Ostomy Confection
An observational study of Colostomy Stoma and Colostomy Complication, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
Trial summary
This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colostomy Stoma, Colostomy Complication, Obstruction Bowel
- What is being tested?
- Intestinal ostomy confection
- Type of treatment
- Surgery or procedure
- How many people
- 154 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2008to Dec 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who underwent emergency surgery between 2008 and 2019 by the surgical team of the Cancer Institute of São Paulo State (Instituto do Câncer do Estado de São Paulo - ICESP)
Who may be able to join
- Patients who underwent emergency colostomy or ileostomy
Who cannot join
- Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto do Câncer do Estado de São Paulo - ICESP
São Paulo, São Paulo, 01246-000
About this study
Official title: Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort
This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).
- Conditions
- Colostomy Stoma, Colostomy Complication, Obstruction Bowel, Surgical Complication, Surgical Procedure, Unspecified
- Being tested
- Intestinal ostomy confection
- Keywords
- colostomy, laparoscopy, ostomy
- Medical subject headings
- Intestinal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intestinal ostomy confectionProcedure or surgery
Surgical procedure for fecal diverting
| Study group | Role | What they receive |
|---|---|---|
| Open Surgery | Not described Receives: Procedure: Intestinal ostomy confection | |
| Laparoscopic Surgery | Not described Receives: Procedure: Intestinal ostomy confection | |
| Trephine Surgery | Not described Receives: Procedure: Intestinal ostomy confection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical complications
Early and late surgical complications related to the stoma and severe complications
Measured: Between cohort enter (2008-2019) and study finish (2021)
Secondary outcomes (1)
Postoperative length of hospital stay
Length of hospital stay after surgery
Measured: Between cohort enter (2008-2019) and study finish (2021)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study startJan 2008
- Primary completionDec 2019
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colostomy StomaStudies 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
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriella Rosceli Campos Zerbetto, Instituto do Cancer do Estado de São Paulo
- Investigators
- Gabriella Rosceli C Zerbetto, Principal investigator, Instituto do Cancer do Estado de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635188
- Sponsor's protocol ID
- 4.834.729
- Status last verified
- Dec 2022
- First submitted
- 22 Nov 2022
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We intend to publish the results of the study, but not make available individual participant date
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Surgical Technique (Laparoscopic, Open or Trephine) on Post-operative Complications in Urgency Ostomy Confection - a Single Center Retrospective Cohort
- ClinicalTrials.gov ID
- NCT05635188
- Acronym / sponsor ID
- 4.834.729
- Conditions
- Colostomy Stoma, Colostomy Complication, Obstruction Bowel, Surgical Complication, Surgical Procedure, Unspecified
- Keywords
- colostomy, laparoscopy, ostomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- Jan 2008 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 2 Dec 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.
This is a single-center retrospective cohort study on cancer patients who underwent emergency ostomy. Our objective was to compare the incidence of surgical complications as well as the length of hospital stay among three different techniques for ostomy confection (laparotomy, the conventional local approach, described as trephination, and laparoscopy).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Open Surgery | – | Procedure: Intestinal ostomy confection |
| Laparoscopic Surgery | – | Procedure: Intestinal ostomy confection |
| Trephine Surgery | – | Procedure: Intestinal ostomy confection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who underwent emergency surgery between 2008 and 2019 by the surgical team of the Cancer Institute of São Paulo State (Instituto do Câncer do Estado de São Paulo - ICESP)
Key inclusion criteria (1 listed)
- Patients who underwent emergency colostomy or ileostomy
Key exclusion criteria (1 listed)
- Patients who underwent other major procedures at the time of the surgery, such as enterectomy, colectomy, or tumor or other organ resection
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 |
|---|---|---|
| Intestinal ostomy confectionSurgical procedure for fecal diverting | Procedure or surgery | Laparoscopic Surgery, Open Surgery, Trephine Surgery |
Primary outcome
Surgical complications
Time frame: Between cohort enter (2008-2019) and study finish (2021)
Early and late surgical complications related to the stoma and severe complications
1 secondary outcome
Postoperative length of hospital stay
Time frame: Between cohort enter (2008-2019) and study finish (2021)
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 5 Dec 2022.
- Individual participant dataSharing planned: No. We intend to publish the results of the study, but not make available individual participant date
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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.
Gabriella Rosceli C Zerbetto principal investigator
Instituto do Cancer do Estado de São Paulo
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 Colostomy Stoma and Colostomy Complication, run by Instituto do Cancer do Estado de São Paulo at 1 site in Brazil.
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 1 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 5 Dec 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 Brazil. 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?
Surgical complications (time frame: Between cohort enter (2008-2019) and study finish (2021)). 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 5 Dec 2022.