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Recruiting

NCT Number: NCT07506005

Anastomotic Bleeding in 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).

Recruiting

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Key information

Conditions

Colorectal Cancer Colonic Diseases Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Intraoperative intraluminal anastomotic bleeding

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

    Intraoperative intraluminal bleeding of the stapling line

Secondary outcomes

  1. Postoperative bleeding

    Time frame: Postoperative

    Postoperative intraluminal anastomotic bleeding

Study contacts

Contact information is provided by the study sponsor or research team.

Sandra Raab, Dr.

CONTACT

[email protected]

+43 (0)5 7680 83 - 2133

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2028
Study completion
2028
First posted
Apr 1, 2026
Registry last updated
Apr 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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