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

NCT ID: NCT05174910

Last Updated: 2024-07-25

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-23
• Study Completion Date: 2024-12-31

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 2x125 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.

Conditions

Anastomotic Leak Rectum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With Obsidian ASG

Anastomosis treatment using standard procedure and Obsidian ASG

Group Type: ACTIVE_COMPARATOR

Obsidian ASG

Intervention Type: DEVICE

Application of an autologous platelet-rich fibrin matrix

Without Obsidian ASG

Anastomosis treatment using standard procedure

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Obsidian ASG

Application of an autologous platelet-rich fibrin matrix

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Raffeiner GmbH

INDUSTRY

Sponsor Role: collaborator

European Commission

OTHER

Sponsor Role: collaborator

AF Schimetta GMbH

UNKNOWN

Sponsor Role: collaborator

Rivolution GmbH

UNKNOWN

Sponsor Role: collaborator

Vivostat

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andreas Shamiyeh, Prim.Doz.Dr.

Role: PRINCIPAL_INVESTIGATOR

Kepler Universitätsklinikum Gmbh

Locations

Krankenhaus der Barmherzigen Brûder

Graz, , Austria

Kepler Universitätsklinikum GmbH, Med campus III

Linz, , Austria

Krankenhaus der Barmherzigen Brüder Wien

Vienna, , Austria

Landesklinikum Wienerneustadt

Wiener Neustadt, , Austria

RoMed Klinikum Rosenheim

Rosenheim, Bavaria, Germany

Universität Augsburg

Augsburg, , Germany

Diakonissenkrankenhaus Dresden

Dresden, , Germany

Klinikum Fürth

Fürth, , Germany

Klinikum Nürnberg Nord

Nuremberg, , Germany

University Milano

Milan, , Italy

University Hospital Belgrade

Belgrade, , Serbia

Granada Hospital

Granada, , Spain

Consorci Hospital General Universitari de Valencia

Valencia, , Spain

Countries

Austria; Germany; Italy; Serbia; Spain

Other Identifiers

ORSY

Identifier Type: -

Identifier Source: org_study_id