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RecruitingNCT07506005Updated Apr 1, 2026

Anastomotic Bleeding in Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line

An observational study in Colorectal Cancer and Diverticulitis, sponsored by Kepler University Hospital. Recruiting at 1 site in Austria. Per ClinicalTrials.gov, last updated 2026-04-01.

Sponsored by Kepler University Hospital · Observational

From the registry’s dates

  • Started Dec 2024; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
102
Sex
All
01

Study 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 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).

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Conditions studied

  • Colorectal Cancer
  • Diverticulitis

Keywords

  • Colorectal anastomosis
  • Double Stapling
  • Anastomotic Bleeding
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In context

Colorectal Neoplasms

6,541 studies on the registry are indexed under Colorectal Neoplasms; 1,667 are open to participants now.

This study's planned enrollment of 102 is below the median of 250 across 1,440 observational studies indexed under Colorectal Neoplasms.

Browse Colorectal Neoplasms studies →

Lead sponsor

Kepler University Hospital is the lead sponsor of 32 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients undergoing colonic surgery (leaving the mesentery - TME ist excluded) and receiving primary anastomosis. Benign and maligne indication.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • TME
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
102 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. Intraoperative intraluminal anastomotic bleeding

    Intraoperative intraluminal bleeding of the stapling line

    Time frame: during surgery until getting the patient is out of the OR

Secondary outcomes

  1. Postoperative bleeding

    Postoperative intraluminal anastomotic bleeding

    Time frame: Postoperative

07

Study locations

1 of 1 sites recruiting
  • Kepler Universit Hospital, Surgical Department
    Linz, 4020, Austria
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07506005
Lead sponsor
Kepler University Hospital
Responsible party
Sponsor
First posted
Apr 1, 2026
Start date
Dec 18, 2024
Primary completion
Dec 1, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 1, 2026

Study contacts

Sandra Raab, Dr.
Contact
sandra.raab@kepleruniklinikum.at
+43 (0)5 7680 83 - 2133

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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