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

Anastomotic Leak Rectum Clinical Trial

— ORSY  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05174910
• Other study ID #: ORSY
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2021
• Est. completion date: December 2024

Study information

• Verified date: May 2023
• Source: Vivostat
• Contact: Peter S Nielsen, MSc
• Phone: +4561728995
• Email: psn[@]vivostat.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 440
• Est. completion date: December 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leak Rectum

Intervention

Device:
• Obsidian ASG
Application of an autologous platelet-rich fibrin matrix

Locations

Country	Name	City	State
Austria	Krankenhaus der Barmherzigen Brûder	Graz
Austria	Kepler Universitätsklinikum GmbH, Med campus III	Linz
Austria	Krankenhaus der Barmherzigen Brüder Wien	Wien
Austria	Landesklinikum Wienerneustadt	Wiener Neustadt
Belgium	UZ Leuven	Leuven
Denmark	University Hospital Aarhus	Aarhus
Germany	Universität Augsburg	Augsburg
Germany	Diakonissenkrankenhaus Dresden	Dresden
Germany	Klinikum Fürth	Fürth
Germany	Klinikum Nürnberg Nord	Nürnberg
Italy	University Milano	Milano
Serbia	University Hospital Belgrade	Belgrade
Spain	Granada Hospital	Granada
Spain	Consorci Hospital General Universitari de Valencia	Valencia

Sponsors (5)

Lead Sponsor	Collaborator
Vivostat	AF Schimetta GMbH, European Commission, Raffeiner GmbH, Rivolution GmbH

Countries where clinical trial is conducted

Austria,  Belgium,  Denmark,  Germany,  Italy,  Serbia,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anastomosis insufficiency [yes/no]	Anastomosis insufficiency after colorectal surgery with primary anastomosis	45 days
Secondary	Anastomotic insufficiency [0/A/B/C]*	*ISREC, International Study Group of Rectal Cancer - severity grading of anastomotic leakage	45 days
Secondary	Staple suture line bleeding requiring surgical intervention [yes, with surgical intervention / yes, without surgical intervention / no]	Staple suture line bleeding requiring surgical intervention	45 days
Secondary	Postoperative hospital length of stay [days]	Days spent in hospital after undergoing colorectal surgery	45 days