Actively Recruiting
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
Eligibility Criteria
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)
You will not qualify if you...
- Total mesorectal excision (TME)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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
Actively Recruiting
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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