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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05174910

Acronym

ORSY

Enrollment

250

Registered

2022-01-03

Start date

2021-12-23

Completion date

2024-12-31

Last updated

2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak Rectum

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.

Interventions

DEVICEObsidian ASG

Application of an autologous platelet-rich fibrin matrix

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Intervention model description

Multicenter, prospective, randomized, single-blind

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Anastomosis insufficiency [yes/no]	45 days	Anastomosis insufficiency after colorectal surgery with primary anastomosis

Secondary

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

Countries

Austria, Germany, Italy, Serbia, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026