Reinforcement of Rectal Anastomosis-RORA

RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02589483

Enrollment

Registered

2015-10-28

Start date

2016-02-29

Completion date

2018-01-31

Last updated

2017-04-13

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

Conditions

Rectal Cancer

Brief summary

The anastomotic leaks are multivariable in its origin. The incidence varies among different centers between 4% and as high as 25%. The impact of leakage in a rectal anastomosis can be devastating for the patient and very costly for the health care system. Prolonged hospital stay (LOS), invasive treatment and intensive care are the consequences. The future of colorectal surgery will increasingly include older patients with increased preoperative morbidity and probably even higher risk for anastomotic leaks. which makes it suitable for reinforcing a rectal anastomosis. The goal is to shift the clinical leaks spectrum into a subclinical and therefore self-healing one.

Detailed description

The rationale is to explore if the procedure of reinforcement with HemoPatch and bringing more mechanical strength over an extended area around the anastomosis thus lowers the incidence of clinical anastomotic leaks. The characteristics of HemoPatch, with its structural properties such as flexibility and tissue adhesion are suitable for this purpose.

Interventions

PROCEDUREThe rectal anastomosis will be reinforced with HemoPatch.

Associated with the making of the anastomosis stapled or hand sewed, the device HemoPatch will be wrapped all the way around the anastomotic circumference.

DEVICEHemopatch

The rectal anastomosis reinforced with Hemopatch

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion criteria

* none

Design outcomes

Primary

Measure	Time frame
Evidence of clinical anastomotic leak( elevated C reactive protein and white blood corpuscles, fever, nausea). Suspicion of a leak will be investigated with a Ct scan.	10 days

Countries

Sweden

Contacts

Primary ContactDan Kornfeld, MD, PhD

dan.kornfeld@capiostgoran.se+46700021820

Backup ContactCarl Leijonmarck, MD, PhD

carl.leijonmarck@capiostgoran.se+467000211821

Outcome results

None listed

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