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

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

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Cancer; Diverticulitis

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).

• Study Type: Observational
• Enrollment (Estimated): 102

Contacts and Locations

• Study Contact: Name: Sandra Raab, Dr.; Phone Number: +43 (0)5 7680 83 - 2133; Email: sandra.raab@kepleruniklinikum.at

Study Locations

• Austria
  • Linz, Austria, 4020
    • Recruiting
    • Kepler Universit Hospital, Surgical Department
    • Contact: Sandra Raab, Dr.; Phone Number: +43 (0)5 7680 83 - 2133; Email: sandra.raab@kepleruniklinikum.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative intraluminal anastomotic bleeding	Intraoperative intraluminal bleeding of the stapling line	during surgery until getting the patient is out of the OR

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative bleeding	Postoperative intraluminal anastomotic bleeding	Postoperative

Collaborators and Investigators

• Sponsor: Kepler University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2024
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: February 23, 2026
• First Submitted That Met QC Criteria: March 29, 2026
• First Posted (Actual): April 1, 2026

Study Record Updates

• Last Update Posted (Actual): April 1, 2026
• Last Update Submitted That Met QC Criteria: March 29, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Colorectal anastomosis; Double Stapling; Anastomotic Bleeding
• Additional Relevant MeSH Terms: Diverticular Diseases; Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colonic Diseases; Gastroenteritis; Colorectal Neoplasms; Diverticulitis
• Other Study ID Numbers: Anas01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No