Anastomotic bleeding after double-stapled colorectal surgery linked to stapler spike position
Anastomotic Bleeding in Primary Double-stapled Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line
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 |
|---|---|
| Enrollment | 102 (estimated) |
| Sex | All |
| Sponsor | Kepler University Hospital Academic / other |
| Locations | 1 site (Linz) |
| Trial ID | NCT07506005 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients having non–double-stapled anastomoses, total mesorectal excision, or procedures for other conditions are unlikely to benefit from the findings.
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 performed: Surgical reports and small case series have suggested stapler spike position can affect bleeding, but no large definitive studies have conclusively proven the effect.
Eligibility criteria
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 this trial is running
Linz
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.