NCT02589483

Reinforcement of Rectal Anastomosis-RORA

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Capio Sankt Görans Hospital · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rectal Cancer

Interventions

Type	Name	Description
PROCEDURE	The 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.
DEVICE	Hemopatch	The rectal anastomosis reinforced with Hemopatch

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-12-01
• Completion: 2018-01-01
• First posted: 2015-10-28
• Last updated: 2017-04-13

Locations

2 sites across 1 country: Sweden