Colorectal CancerTDRAINNCT03974672
A T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
An observational study of Colorectal Cancer and Diverticulitis, run by Meir Medical Center at 1 site in Israel.
Trial summary
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer, Diverticulitis
- What is being tested?
- Re-laparotomy
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- 1 Jan 2014to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis
Who may be able to join
- Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis
Who cannot join
- under 18 years of age
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.
Read the detailed description
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.
- Conditions
- Colorectal Cancer, Diverticulitis
- Being tested
- Re-laparotomy
- Medical subject headings
- Colorectal Neoplasms, Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Re-laparotomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| T drain | Patients treated with a T drain approach Receives: Procedure: Re-laparotomy | |
| Stoma | Patients treated with a stoma Receives: Procedure: Re-laparotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measuring severity of complications with the Dindo Clavien complications scale
By using the Dindo Clavien complications scale assessment of recuperation and complications rate and severity following re-laparotomy and assessing if another surgery was avoided.
Measured: 30 day post operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Jan 2014
- Primary completion31 Dec 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meir Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yaron rudnicki, Meir Medical Center
- Investigators
- Yaron Rudnicki, MD, Principal investigator, Meir Medical Center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03974672
- Sponsor's protocol ID
- MMC-0340-16-CTIL
- Acronym
- TDRAIN
- Status last verified
- Jun 2019
- First submitted
- 26 May 2019
- Last updated
- 5 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All none identifying patients information
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Retrospective Study Using a T Drain Approach Treating Anastomotic Leaks After Gastrointestinal Surgery
- ClinicalTrials.gov ID
- NCT03974672
- Acronym / sponsor ID
- TDRAIN / MMC-0340-16-CTIL
- Conditions
- Colorectal Cancer, Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Meir Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 5 Jun 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.
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The study's aim is to retrospectively assess the safety and benefits of this approach.
Detailed description
Assessing the use of a T drain approach for an anastomotic leak after gastrointestinal surgery. The T drain approach is inserting a latex t tube drain into the leak site of the anastomosed bowel and diverting the fecal matter. The study's aim is to retrospectively assess the safety and benefits of this approach.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| T drain | – | Procedure: Re-laparotomyPatients treated with a T drain approach |
| Stoma | – | Procedure: Re-laparotomyPatients treated with a stoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis
Key inclusion criteria (1 listed)
- Patients after elective or emergent gastrointestinal surgery with a leak in their GI anastomosis
Key exclusion criteria (2 listed)
- under 18 years of age
- Pregnancy
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 |
|---|---|---|
| Re-laparotomy | Procedure or surgery | Stoma, T drain |
Primary outcome
Measuring severity of complications with the Dindo Clavien complications scale
Time frame: 30 day post operation
By using the Dindo Clavien complications scale assessment of recuperation and complications rate and severity following re-laparotomy and assessing if another surgery was avoided.
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 Jun 2019.
- Individual participant dataSharing planned: Undecided. All none identifying patients information
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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.
Yaron Rudnicki, MD principal investigator
Meir Medical Center Israel
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 Colorectal Cancer and Diverticulitis, run by Meir Medical Center at 1 site in Israel.
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 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 5 Jun 2019. 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 Israel. 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?
Measuring severity of complications with the Dindo Clavien complications scale (time frame: 30 day post operation). 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 Jun 2019.