Anastomotic LeakNCT06553261
Anastomotic Leakage in Right Colectomy
An observational study of Anastomotic Leak, run by Barmherzige Brüder Vienna at 1 site in Austria.
Trial summary
Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Leak
- What is being tested?
- suturing of leak, lavage, drainage, Formation of a new anasthomosis and Fecal diversion
- Type of treatment
- Surgery or procedure
- How many people
- 3,446 participants
- Where
- 1 siteAustria
- Study dates
- 12 Aug 2024to 12 Dec 2024
- 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 with benign or malignant diseases in the right colon.
Who may be able to join
- Patients with benign or malignant diseases in the right portion of the colon.
- elective surgery
Who cannot join
- emergent surgery
Trial locations and contacts
1 site in 1 country.
Austria1 site, 1 recruiting
- Recruiting
Krankenhaus der Barmherzigen Brüder
Vienna, 1020
Benhard Dauser, Assoc. Prof., 0043 1 211210 ext. 5098, bernhard.dauser@gmail.com
Iliyan Iliev, MD, 0043 6607435277, iliyaniliev18s@gmail.com
About this study
Official title: Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study
Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.
- Conditions
- Anastomotic Leak
- Being tested
- suturing of leak, lavage, drainage, Formation of a new anasthomosis, Fecal diversion
- Medical subject headings
- Anastomotic Leak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
suturing of leak, lavage, drainageProcedure or surgery
Operative suturing of the leak, lavage, drainage within a revision surgery.
Formation of a new anasthomosisProcedure or surgery
Operative resection of the old leaking anastomosis and formation of a new one.
Fecal diversionProcedure or surgery
Formation of a deviating stoma.
| Study group | Role | What they receive |
|---|---|---|
| Patients after laparoscopic right hemicolectomy | Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak. Receives: Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion | |
| Patients after open right hemicolectomy | Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak. Receives: Procedure: suturing of leak, lavage, drainage; Procedure: Formation of a new anasthomosis; Procedure: Fecal diversion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical outcome
Survival or death
Measured: 2010-2019
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2024
- Study start12 Aug 2024 (estimated)
- Primary completion12 Oct 2024 (estimated)
- Study completion12 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anastomotic LeakStudies 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
- 3,446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barmherzige Brüder Vienna
- Sponsor type
- University, hospital or other
- Collaborators
- Barmherzige Brüder Salzburg, Kepler University Hospital, University of Salzburg, Hospital Barmherzige Schwestern Vienna, Medical University of Vienna, University Hospital, Saarland, Sigmund Freud PrivatUniversitat
- Responsible party
- Principal investigator, ILIYAN ILIEV, Barmherzige Brüder Vienna
- Investigators
- Bernhard Dauser, Assoc. Prof., Principal investigator, Krankenhaus der Barmherzigen Brüder Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06553261
- Sponsor's protocol ID
- LEAK1
- Status last verified
- Aug 2024
- First submitted
- 11 Aug 2024
- Last updated
- 14 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT06553261
- Acronym / sponsor ID
- LEAK1
- Conditions
- Anastomotic Leak
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 3,446 participants (estimated)
- Lead sponsor
- Barmherzige Brüder ViennaUniversity, hospital or other
- Collaborators
- Barmherzige Brüder Salzburg, Kepler University Hospital, University of Salzburg, Hospital Barmherzige Schwestern Vienna, Medical University of Vienna, University Hospital, Saarland, Sigmund Freud PrivatUniversitat
- Study start
- 12 Aug 2024 (estimated)
- Primary completion
- 12 Oct 2024 (estimated)
- Study completion
- 12 Dec 2024 (estimated)
- First posted
- 14 Aug 2024 (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.
Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients after laparoscopic right hemicolectomy | – | Procedure: suturing of leak, lavage, drainage, Procedure: Formation of a new anasthomosis, Procedure: Fecal diversionPatients who had undergone a laparoscopic tight colectomy and had anastomotic leak. |
| Patients after open right hemicolectomy | – | Procedure: suturing of leak, lavage, drainage, Procedure: Formation of a new anasthomosis, Procedure: Fecal diversionPatients who had undergone a laparoscopic tight colectomy and had anastomotic leak. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign or malignant diseases in the right colon.
Key inclusion criteria (2 listed)
- Patients with benign or malignant diseases in the right portion of the colon.
- elective surgery
Key exclusion criteria (1 listed)
- emergent 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 |
|---|---|---|
| suturing of leak, lavage, drainageOperative suturing of the leak, lavage, drainage within a revision surgery. | Procedure or surgery | Patients after laparoscopic right hemicolectomy, Patients after open right hemicolectomy |
| Formation of a new anasthomosisOperative resection of the old leaking anastomosis and formation of a new one. | Procedure or surgery | Patients after laparoscopic right hemicolectomy, Patients after open right hemicolectomy |
| Fecal diversionFormation of a deviating stoma. | Procedure or surgery | Patients after laparoscopic right hemicolectomy, Patients after open right hemicolectomy |
Primary outcome
Clinical outcome
Time frame: 2010-2019
Survival or death
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Bernhard Dauser, Assoc. Prof. principal investigator
Krankenhaus der Barmherzigen Brüder Vienna
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 Anastomotic Leak, run by Barmherzige Brüder Vienna at 1 site in Austria.
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: status not confirmed, as of the sponsor's last update on 14 Aug 2024. 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 Austria. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bernhard Dauser, Assoc. Prof. (0043 1 211210 ext. 5098, bernhard.dauser@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical outcome (time frame: 2010-2019). 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 14 Aug 2024.