Colorectal CancerNCT07506005
Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
An observational study of Colorectal Cancer and Diverticulitis, run by Kepler University Hospital at 1 site in Austria.
Trial summary
Each colorectal anastomosis is routinely evaluated intraoperatively by sigmoidoscopy and, in the presence of signs of bleeding, also postoperatively (persistent rectal bleeding within 24 hours after surgery). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Colorectal Cancer, Diverticulitis
- How many people
- 102 participants
- Where
- 1 siteAustria
- Study dates
- 18 Dec 2024to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 undergoing colonic surgery (leaving the mesentery - TME ist excluded) and receiving primary anastomosis. Benign and maligne indication.
Who may be able to join
- Age ≥ 18 years
- Colorectal surgery with primary colorectal anastomosis using the double-stapling technique, including side-to-end or end-to-end anastomosis
- Documented anastomotic orientation (mesenteric vs. antimesenteric)
Who cannot join
- TME
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Austria1 site, 1 recruiting
- Recruiting
Kepler Universit Hospital, Surgical Department
Linz, 4020
Sandra Raab, Dr., +43 (0)5 7680 83 - 2133, sandra.raab@kepleruniklinikum.at
About this study
Official title: Anastomotic Bleeding in Primary Double-stapled Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
Each colorectal anastomosis is routinely evaluated intraoperatively by sigmoidoscopy and, in the presence of signs of bleeding, also postoperatively (persistent rectal bleeding within 24 hours after surgery).
Read the detailed description
The aim of this study is to assess the incidence of anastomotic bleeding in double-stapled anastomoses in relation to the position of the trocar relative to the rectal staple line (on the mesenteric side of the rectal staple line versus opposite the mesenteric side).
- Conditions
- Colorectal Cancer, Diverticulitis
- Keywords
- Colorectal anastomosis, Double Stapling, Anastomotic Bleeding
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Mesenteric | Spike comes out on the side of the mesenterium according to to linear staple line | |
| Antimesenteric | Spike comes out not on the side of the mesentery according to to linear staple line |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative intraluminal anastomotic bleeding
Intraoperative intraluminal bleeding of the stapling line
Measured: during surgery until getting the patient is out of the OR
Secondary outcomes (1)
Postoperative bleeding
Postoperative intraluminal anastomotic bleeding
Measured: Postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2026
- Study start18 Dec 2024
- Primary completion1 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
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
- Prospective
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kepler University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07506005
- Sponsor's protocol ID
- Anas01
- Status last verified
- Mar 2026
- First submitted
- 23 Feb 2026
- Last updated
- 1 Apr 2026
- 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 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anastomotic Bleeding in Primary Double-stapled Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
- ClinicalTrials.gov ID
- NCT07506005
- Acronym / sponsor ID
- Anas01
- Conditions
- Colorectal Cancer, Diverticulitis
- Keywords
- Colorectal anastomosis, Double Stapling, Anastomotic Bleeding
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Kepler University HospitalUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 1 Apr 2026 (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.
Each colorectal anastomosis is routinely evaluated intraoperatively by sigmoidoscopy and, in the presence of signs of bleeding, also postoperatively (persistent rectal bleeding within 24 hours after surgery).
Detailed description
The aim of this study is to assess the incidence of anastomotic bleeding in double-stapled anastomoses in relation to the position of the trocar relative to the rectal staple line (on the mesenteric side of the rectal staple line versus opposite the mesenteric side).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenteric | – | –Spike comes out on the side of the mesenterium according to to linear staple line |
| Antimesenteric | – | –Spike comes out not on the side of the mesentery according to to linear staple line |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing colonic surgery (leaving the mesentery - TME ist excluded) and receiving primary anastomosis. Benign and maligne indication.
Key inclusion criteria (3 listed)
- Age ≥ 18 years
- Colorectal surgery with primary colorectal anastomosis using the double-stapling technique, including side-to-end or end-to-end anastomosis
- Documented anastomotic orientation (mesenteric vs. antimesenteric)
Key exclusion criteria (1 listed)
- TME
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative intraluminal anastomotic bleeding
Time frame: during surgery until getting the patient is out of the OR
Intraoperative intraluminal bleeding of the stapling line
1 secondary outcome
Postoperative bleeding
Time frame: Postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- 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.
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 Kepler University Hospital 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 3 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sandra Raab, Dr. (+43 (0)5 7680 83 - 2133, sandra.raab@kepleruniklinikum.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative intraluminal anastomotic bleeding (time frame: during surgery until getting the patient is out of the OR). 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 1 Apr 2026.