Clinical trial Recruiting at 1 site Observational

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 typeObservational
SexAll
Enrollment102 (estimated)
SponsorKepler University Hospital
Academic / other
Locations1 site (Linz)
StatusRecruiting
StartedDecember 18, 2024
Main results expectedDecember 1, 2028
Study endsDecember 31, 2028
Registry record updatedApril 1, 2026
Trial IDNCT07506005 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.