Reinforcement of Rectal Anastomosis-RORA

Capio Sankt Görans Hospital

Status: Unknown

Conditions: Rectal Cancer

Treatments: Procedure: The rectal anastomosis will be reinforced with HemoPatch.; Device: Hemopatch

Study type: Interventional

Funder types: Other

Identifiers

NCT02589483

Baxter

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion criteria

• none

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Prospective pilot

Experimental group

Description:

Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.

Treatment:

Procedure: The rectal anastomosis will be reinforced with HemoPatch.

Device: Hemopatch