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OpenTrials
Completed

NCT Number: NCT04386148

Impact of Obsidian ® ASG on Anastomotic Healing

The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.

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Key information

Conditions

Anastomotic Leak Rectum Anastomotic Leak Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for General and Visceral Surgery, Kepler University Clinic Linz

Linz, Upper Austria, 4020, Austria

About this study

Introduction:

The use of regenerative medicine in colorectal surgery constitutes an entirely new therapeutic principle. The aim of this new therapeutic approach is to reduce the anastomotic leak rate and minimise morbidity and mortality. The literature identifies the leak rate for colorectal operations as 3-39%.

Methods:

This is a prospective, multi-centre descriptive study commencing in June 2018. As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

elective laparoscopic colorectal surgery with a primary anastomosis treatment

Exclusion criteria

  • pregnancy
  • Breastfeeding period
  • concomitant disease with the potential for a relevant impairment of the anastomosis durability (leukemia, cirrhosis of the liver, Child Pugh A-C)

Treatment and study plan

Obsidian ASG®

Procedure

As part of the elective laparoscopic colorectal surgery, an autologous fibrin matrix was used as part of anastomotic technique in conjunction with activated thrombocytes (Obsidian ASG®). During anastomosis, this matrix was applied after resection onto the colorectal tissue surfaces with the aim of triggering tissue regeneration and improved wound healing.

Primary outcomes

  1. Anastomotic leak rate

    Time frame: 20 days

    Anastomotic leak rate after colorectal surgery with Primary anastomosis

Secondary outcomes

  1. feacal blood

    Time frame: 20 days

    number of Patients with feacal blood after colorectal surgery with Primary anastomosis

  2. fever

    Time frame: 20 days

    number of patients with fever higher than 38°C after colorectal surgery

  3. length of Hospital stay

    Time frame: 20 days

    days spent in Hospital after undergoing colorectal surgery

Sponsors and collaborators

Lead sponsor

Kepler University Hospital

Other

Registry information

Official study title

Impact of Obsidian® ASG Autologous Platelet-rich Fibrin Matrix on Anastomotic Healing in Colorectal Surgery

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
May 13, 2020
Registry last updated
Oct 5, 2023

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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