Anastomotic bleeding after double-stapled colorectal surgery linked to stapler spike position
Official title: Anastomotic Bleeding in Primary Double-stapled Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
Run by Kepler University Hospital · NCT07506005 · Data updated 2026-11-12
This project will see if placing the stapler spike on the mesenteric versus the opposite side affects early rectal bleeding in adults having double-stapled colorectal anastomoses for cancer or diverticulitis.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Kepler University Hospital Academic / other |
| Locations | 1 site (Linz) |
| Status | Recruiting |
| Started | December 18, 2024 |
| Main results expected | December 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 1, 2026 |
| Trial ID | NCT07506005 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (18 and older) undergoing colorectal resection with a primary double-stapled anastomosis for colorectal cancer or diverticulitis, with the anastomotic orientation documented and not undergoing TME, are ideal candidates.
✕Probably not a fit
Patients having non–double-stapled anastomoses, total mesorectal excision, or procedures for other conditions are unlikely to benefit from the findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a single-center observational study that records the orientation of the trocar/spike relative to the rectal staple line in double-stapled colorectal anastomoses and tracks bleeding outcomes. Each anastomosis is inspected intraoperatively by sigmoidoscopy and postoperative persistent rectal bleeding within 24 hours is documented. The primary comparison is incidence of anastomotic bleeding when the spike is placed on the mesenteric side versus the antimesenteric side. Adult patients with documented anastomotic orientation are included, while procedures involving total mesorectal excision are excluded.
Why it matters
Potential benefit: If successful, surgeons could reduce early anastomotic bleeding by adopting a preferred stapler spike position during double-stapled colorectal anastomosis.
How similar studies have gone: Surgical reports and small case series have suggested stapler spike position can affect bleeding, but no large definitive studies have conclusively proven the effect.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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) Exclusion Criteria: * TME
Where it's running
-
Kepler Universit Hospital, Surgical Department
Linz, Austria Recruiting
Study contacts
- Study coordinator: Sandra Raab, Dr.
- Email: sandra.raab@kepleruniklinikum.at
- Phone: +43 (0)5 7680 83 - 2133
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.