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Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery (ORSY)

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ClinicalTrials.gov Identifier: NCT05174910
Recruitment Status : Recruiting
First Posted : January 3, 2022
Last Update Posted : May 12, 2023
Sponsor:
Collaborators:
Raffeiner GmbH
AF Schimetta GMbH
Rivolution GmbH
European Commission
Information provided by (Responsible Party):
Vivostat

Study Description
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Brief Summary:

Anastomotic insufficiency remains one of the most significant problems after rectal resection.The complications following anastomotic insufficiency leads to increased morbidity and mortality with subsequent prolongation of hospital stay and higher costs.

This study is an investigation of the benefit of using an autologous platelet-rich fibrin matrix (Obsidian ASG®) for treatment of anastomosis during rectal surgery - a single-blind, randomized, multicenter pilot study with enrollment of 2x220 patients

The main objective of the study is to investigate on an exploratory basis whether the use of Obsidian ASG® during rectal resection reduces the frequency of postoperative anastomotic insufficiency compared to standard anastomotic technique.

The secondary objectives of the study are to investigate on an exploratory basis:

  • The frequency of anastomotic insufficiency (ISREC Criteria) severity
  • Staple line bleeding requiring surgical intervention
  • The duration of postoperative hospitalization are reduced when using Obsidian ASG ® compared with standard anastomotic treatment alone.

are reduced when Obsidian ASG ® is added to the standard of anastomotic treatment compared with standard anastomotic treatment alone.


Condition or disease Intervention/treatment Phase
Anastomotic Leak Rectum Device: Obsidian ASG Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Multicenter, prospective, randomized, single-blind
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigation of the Benefit of Using an Autologous Platelet-rich Fibrin Matrix (Obsidian ASG®) for Treatment of Anastomosis During Rectal Surgery - a Single-blind, Randomized, Multicenter Pilot Study
Actual Study Start Date : December 23, 2021
Estimated Primary Completion Date : October 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: With Obsidian ASG
Anastomosis treatment using standard procedure and Obsidian ASG
 Device: Obsidian ASG
Application of an autologous platelet-rich fibrin matrix
No Intervention: Without Obsidian ASG
Anastomosis treatment using standard procedure


Outcome Measures
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Primary Outcome Measures :
  1. Anastomosis insufficiency [yes/no] [ Time Frame: 45 days ]
    Anastomosis insufficiency after colorectal surgery with primary anastomosis


Secondary Outcome Measures :
  1. Anastomotic insufficiency [0/A/B/C]* [ Time Frame: 45 days ]
    *ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage

  2. Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no] [ Time Frame: 45 days ]
    Staple suture line bleeding requiring surgical intervention

  3. Postoperative hospital length of stay [days] [ Time Frame: 45 days ]
    Days spent in hospital after undergoing colorectal surgery


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

The following inclusion criteria will be considered:

  • Written informed consent
  • Age > 18 years
  • Indication for elective oncological rectal resection in the presence of malignant rectal disease and the lower edge of the tumor, measured from the anal verge with the rigid rectoscope, ≤ 14cm
  • Use of a circular anastomosis using the "double stapling technique"(6) during creation of the anastomosis
  • Expected availability within the maximum 45-day period of study participation
  • The use of "golden standard" stapling technology devices; 3 rows endo linear stapler; 2 rows circular stapling devices should be used in an open and laparoscopic approach

Exclusion Criteria:

The following exclusion criteria will be considered:

  • Pregnancy, or the non-exclusion of pregnancy (for women of childbearing potential). In the case of menopause having occurred more than 2 years ago or postmenopausal sterilization or surgical sterilization, the authorized physician is free to classify the female study participant as non-pregnant, so that the pregnancy test otherwise required at the beginning of study participation (or during subject screening) may be omitted.
  • Risk of pregnancy occurring while taking part in the study in women not meeting at least one of the following criteria: Onset of menopause more than 2 years ago, postmenopausal sterilization, surgical sterilization, a promise to use contraception (with hormones, coil or diaphragm/condom + spermicide), while enrolled in the study) In the case of onset of menopause more than 2 years ago, postmenopausal sterilization or surgical sterilization, the authorized doctor is free to classify the patient in question as infertile. Furthermore, it is at the discretion of the authorized physician to classify the patient in question on the basis of continuous inpatient care in such a way that the occurrence of pregnancy during participation in the study can be ruled out ("continuous determination of the absence of pregnancy"). If one of the above classifications applies, further measures to ensure that a pregnancy does not occur during the patient's participation in the study may not be required.
  • Breastfeeding period
  • Lack of legal capacity
  • Vulnerable persons according to the law
  • Comorbidity with the potential for relevant impairment of anastomosis durability (leukemia, cirrhosis of the liver, Child Pugh C, etc.)
  • Preoperative anemia with Hb <8g/dL
  • Participating in another study
  • Patients on Aspirin not able to stop using Aspirin for medical reasons minimum 3 days before taking the blood sampling.
  • Patients on Clopidogrel not able to stop using Clopidogrel for medical reasons minimum 7 days before blood sampling.
  • Patients on other platelet aggregation inhibitor therapies
  • Contraindication for Obsidian ASG®
  • Surgical technique of transanal total mesorectal excision (TaTME)
  • Application of a circular powered stapler in the course of anastomosis supply with GSTTM technology or a 3 row circular stapler use while creating the study anastomosis
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05174910


Contacts
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Contact: Peter S Nielsen, MSc +4561728995 psn@vivostat.com
Contact: Sven Lange, MSc +4560108868 sla@vivostat.com

Locations
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Austria
Krankenhaus der Barmherzigen Brûder Recruiting
Graz, Austria, 8020
Contact: Felex Aigner, Prim.Doz.Dr       felix.aigner@bbgraz.at   
Kepler Universitätsklinikum GmbH, Med campus III Recruiting
Linz, Austria, 4021
Contact: Andreas Shamiyeh, Prim.Doz.Dr.       Andreas.Shamiyeh@kepleruniklinikum.at   
Landesklinikum Wienerneustadt Recruiting
Wiener Neustadt, Austria, 2700
Contact: Friedrich Längle, Prof. Dr.       Friedrich.Laengle@wienerneustadt.lknoe.at   
Krankenhaus der Barmherzigen Brüder Wien Recruiting
Wien, Austria, 4041
Contact: Friedrich Hersbst, Prof. Dr.       friedrich.herbst@bbwien.at   
Belgium
UZ Leuven Not yet recruiting
Leuven, Belgium, 3000
Contact: Andre D'Hoore, Prof. Dr.       andre.dhoore@uzleuven.be   
Denmark
University Hospital Aarhus Not yet recruiting
Aarhus, Denmark, 8200
Contact: Leni Iverson, Prof. Dr.       lenive@rm.dk   
Germany
Universität Augsburg Recruiting
Augsburg, Germany, 86152
Contact: Sebastian Wolf, Dr.       sebastian.wolf@uk-augsburg.de   
Diakonissenkrankenhaus Dresden Recruiting
Dresden, Germany, 01099
Contact: Thorsten Jacobi, Dr. Med.       thorsten.jacobi@diako-dresden.de   
Klinikum Fürth Recruiting
Fürth, Germany, 90766
Contact: Katica Krajinovic, Priv.Doz.Dr.       Katica.Krajinovic@klinikum-fuerth.de   
Klinikum Nürnberg Nord Recruiting
Nürnberg, Germany, 90419
Contact: Mohamed Hanout, Dr. Prof.       mohamed.hanout@klinikum-nuernberg.de   
Italy
University Milano Recruiting
Milano, Italy, 20122
Contact: Luigi Boni, Prof. Dr.       luigi.boni@unimi.it   
Serbia
University Hospital Belgrade Recruiting
Belgrade, Serbia, 11000
Contact: Miljan Ceranic, Dr.       miljanceranic1972@gmail.com   
Spain
Granada Hospital Recruiting
Granada, Spain, 18016
Contact: Jorge Sanfiel, Dr.       jorgers91@gmail.com   
Consorci Hospital General Universitari de Valencia Recruiting
Valencia, Spain, 46016
Contact: Antonio S. Martinez, Dr.       toncla@comv.es   
Sponsors and Collaborators
Vivostat
Raffeiner GmbH
AF Schimetta GMbH
Rivolution GmbH
European Commission
Investigators
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Principal Investigator: Andreas Shamiyeh, Prim.Doz.Dr. Kepler Universitätsklinikum Gmbh
More Information
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Responsible Party: Vivostat
ClinicalTrials.gov Identifier: NCT05174910    
Other Study ID Numbers: ORSY
First Posted: January 3, 2022    Key Record Dates
Last Update Posted: May 12, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Anastomotic Leak
Postoperative Complications
Pathologic Processes