Impact of Obsidian ® ASG on Anastomotic Healing

NCT04386148 | Completed

• 1 other identifier: Obsidian-20
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

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%.

Conditions

Anastomotic Leak Rectum

Keywords

Colorectal surgery; Anastomotic leak; Obisidan

Outcome Measures

Primary Outcomes (1)

• Anastomotic leak rate

  Anastomotic leak rate after colorectal surgery with Primary anastomosis

  20 days

Secondary Outcomes (3)

• feacal blood

  20 days

• fever

  20 days

• length of Hospital stay

  20 days

Study Arms (1)

laparoscopic colorectal surgery

Patients undergoing laparoscopic colorectal surgery with use of Obsidian ASG® during primary anastomosis.

Procedure: Obsidian ASG®

Interventions

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.

laparoscopic colorectal surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who undergoing elective laparoscopic colorectal surgery with a primary left-sided anastomosis treatment

You may qualify if:

• elective laparoscopic colorectal surgery with a primary anastomosis treatment

You may not qualify if:

• 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)

Sponsors & Collaborators

• Kepler University Hospital: lead

Study Sites (1)

Clinic for General and Visceral Surgery, Kepler University Clinic Linz

Linz, Upper Austria, 4020, Austria

Location

Related Publications (3)

• Fraccalvieri D, Biondo S, Saez J, Millan M, Kreisler E, Golda T, Frago R, Miguel B. Management of colorectal anastomotic leakage: differences between salvage and anastomotic takedown. Am J Surg. 2012 Nov;204(5):671-6. doi: 10.1016/j.amjsurg.2010.04.022. Epub 2011 May 19.

  PMID: 21600561 BACKGROUND

• Rahbari NN, Weitz J, Hohenberger W, Heald RJ, Moran B, Ulrich A, Holm T, Wong WD, Tiret E, Moriya Y, Laurberg S, den Dulk M, van de Velde C, Buchler MW. Definition and grading of anastomotic leakage following anterior resection of the rectum: a proposal by the International Study Group of Rectal Cancer. Surgery. 2010 Mar;147(3):339-51. doi: 10.1016/j.surg.2009.10.012. Epub 2009 Dec 11.

  PMID: 20004450 BACKGROUND

• Buchs NC, Gervaz P, Secic M, Bucher P, Mugnier-Konrad B, Morel P. Incidence, consequences, and risk factors for anastomotic dehiscence after colorectal surgery: a prospective monocentric study. Int J Colorectal Dis. 2008 Mar;23(3):265-70. doi: 10.1007/s00384-007-0399-3. Epub 2007 Nov 22.

  PMID: 18034250 BACKGROUND

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2020
• First Posted: May 13, 2020
• Study Start: June 1, 2018
• Primary Completion: March 31, 2021
• Study Completion: December 31, 2021
• Last Updated: October 5, 2023

Record last verified: 2023-10

Locations

AU (1)