Ileostomy - StomaNCT04169425
Laparoscopic Surgery of Rectal Cancer and Ileostomy
An observational study of Ileostomy - Stoma and Ileostomy; Complications, run by Campus Bio-Medico University.
Trial summary
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed. Read more about this study
- Who is it for?
- Ages 67 to 86 years
- Conditions the study is for
- Ileostomy - Stoma, Ileostomy; Complications, Leakage, Anastomotic
- What is being tested?
- elective diverting ileostomy
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 2 Jan 2012to 1 Feb 2018
- 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 67 to 86 years
- All sexes
- No healthy volunteers
- Older adult
Study population: Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma.
Who may be able to join
- adult patients (aged 18 years and over)
- patients submitted to elective Anterior Rectal Resection
Who cannot join
- chronic use of immunosuppressant agents
- urgent surgery
About this study
Official title: Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.
Read the detailed description
From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.
- Being tested
- elective diverting ileostomy
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elective diverting ileostomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | patients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer Receives: Procedure: elective diverting ileostomy | |
| Group 2 | patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with anastomotic leakage
Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema
Measured: 90 days
Secondary outcomes (7)
Number of participants with post-operative complications
post-operative complication in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever
post-operative fever in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with surgical site infection
post-operative surgical site infection in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with abdominal collections
post-operative abdominal collections in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with anastomotic bleeding
post-operative anastomotic bleeding in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with perforation
post-operative perforation in patients submitted to Anterior Rectal Resection
Measured: 90 days
Number of participants with anastomotic stenosis
post-operative anastomotic stenosis in patients submitted to Anterior Rectal Resection
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start2 Jan 2012
- Primary completion22 Dec 2017
- Study completion1 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ileostomy - 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
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campus Bio-Medico University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vincenzo La Vaccara, Campus Bio-Medico University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04169425
- Sponsor's protocol ID
- 11.17 OSS Comet CBM
- Status last verified
- Nov 2019
- First submitted
- 17 Nov 2019
- Last updated
- 21 Nov 2019
- 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 21 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Surgery of Rectal Cancer and Ileostomy. Technological Progress in Relation to New Minimally Invasive Treatment Methods and the Incidence of Complications.
- ClinicalTrials.gov ID
- NCT04169425
- Acronym / sponsor ID
- 11.17 OSS Comet CBM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Campus Bio-Medico UniversityUniversity, hospital or other
- Study start
- 2 Jan 2012
- Primary completion
- 22 Dec 2017 (actual)
- Study completion
- 1 Feb 2018 (actual)
- First posted
- 19 Nov 2019 (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.
Elective diverting ileostomy may reduce consequences of anastomotic failure in laparoscopic TME. Aiming to evaluate the effectiveness of elective diverting ileostomy, its impact on the incidence and clinical behavior of anastomotic leakage and the complications related to its presence and take down were analyzed.
Detailed description
From a prospective collected database, data regarding patients who underwent to laparoscopic TME, with (Group 1) or without (Group 2) elective diverting ileostomy for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma, have been retrospectively analyzed.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | Procedure: elective diverting ileostomypatients who underwent to laparoscopic TME, with elective diverting ileostomy for rectal cancer |
| Group 2 | – | –patients who underwent to laparoscopic TME, without elective diverting ileostomy for rectal cancer |
Who may qualify
- Ages
- 67 to 86 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients who underwent to laparoscopic TME, for rectal cancer from 2012 to 2017 at University Campus Bio-Medico di Roma.
Key inclusion criteria (2 listed)
- adult patients (aged 18 years and over)
- patients submitted to elective Anterior Rectal Resection
Key exclusion criteria (2 listed)
- chronic use of immunosuppressant agents
- urgent surgery
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 |
|---|---|---|
| elective diverting ileostomy | Procedure or surgery | Group 1 |
Primary outcome
Number of participants with anastomotic leakage
Time frame: 90 days
Leakage was defined on the basis of perianastomotic drain appearance and/or of radiological findings during postoperative X-Ray or abdominal CT scan enema
7 secondary outcomes
Number of participants with post-operative complications
Time frame: 90 days
Number of participants with fever Surgical site infection Abdominal collections Anastomotic leakage Anastomotic bleeding Perforation Anastomotic stenosis Number of participants with fever
Time frame: 90 days
Number of participants with surgical site infection
Time frame: 90 days
Number of participants with abdominal collections
Time frame: 90 days
Number of participants with anastomotic bleeding
Time frame: 90 days
Number of participants with perforation
Time frame: 90 days
Number of participants with anastomotic stenosis
Time frame: 90 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 21 Nov 2019.
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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 Ileostomy - Stoma and Ileostomy; Complications, run by Campus Bio-Medico University.
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 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 21 Nov 2019. 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?
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?
Number of participants with anastomotic leakage (time frame: 90 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 21 Nov 2019.