Actively Recruiting

All Genders
ID07506005

Anastomotic Bleeding in Primary Double-stapled Colorectal Anastomosis Relating to the Placement of the Stapler Spike to the Staple Line

Led by Kepler University Hospital · Updated on 2026-04-01

102

Participants Needed

1

Research Sites

4 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to assess how the position of the stapler spike relative to the rectal staple line affects anastomotic bleeding during colorectal surgery. It focuses on patients undergoing colorectal surgery with primary double-stapled anastomosis, including side-to-end or end-to-end anastomoses. The study involves patients with conditions such as colorectal cancer and diverticulitis. The study compares two groups based on the placement of the stapler spike: one where the spike emerges on the mesenteric side of the linear staple line and another where it comes out on the opposite side. During surgery, each colorectal anastomosis is routinely evaluated by sigmoidoscopy to check for intraluminal bleeding. Postoperative bleeding is also monitored if persistent rectal bleeding occurs within 24 hours after surgery. Participants are closely monitored during and after surgery with evaluations focusing on intraoperative bleeding until the patient leaves the operating room and postoperative bleeding afterward. The research team documents anastomotic orientation and assesses bleeding events to understand the relationship with the stapler spike placement. The total study duration extends to the end of 2028, with detailed observations during and after the surgical procedure.

CONDITIONS

Brief Title

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

Who Can Participate

All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 65 18 years
  • Undergoing 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)
Not Eligible

You will not qualify if you...

  • Total mesorectal excision (TME)

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Surgery day and hospital stay until discharge

Participants undergo colorectal surgery with primary double-stapled colorectal anastomosis, during which the position of the stapler spike relative to the staple line is documented. Intraoperative bleeding is assessed until the patient leaves the operating room.

1 surgical procedure and immediate post-operative observation

Post-operative Follow-up

Duration - Postoperative period (duration as per clinical care)

Participants are monitored for any postoperative bleeding following surgery.

Approximately 1 to 2 follow-up visits depending on clinical need

Trial Site Locations

Total: 1 location

1

Kepler Universit Hospital, Surgical Department

Linz, Austria, 4020

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Research Team

S

Sandra Raab, Dr.

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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