Reinforcement of Rectal Anastomosis-RORA

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02589483
• Other study ID #: Baxter
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2015
• Last updated: April 12, 2017
• Start date: February 2016
• Est. completion date: January 2018

Study information

• Verified date: April 2017
• Source: Capio Sankt Görans Hospital
• Contact: Dan Kornfeld, MD, PhD
• Phone: +46700021820
• Email: dan.kornfeld[@]capiostgoran.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: January 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Dan Kornfeld	Stockholm
Sweden	Dan Kornfeld	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Capio Sankt Görans Hospital

Country where clinical trial is conducted

Sweden, 

References & Publications (3)

Bruce J, Krukowski ZH, Al-Khairy G, Russell EM, Park KG. Systematic review of the definition and measurement of anastomotic leak after gastrointestinal surgery. Br J Surg. 2001 Sep;88(9):1157-68. Review. — View Citation

Daams F, Luyer M, Lange JF. Colorectal anastomotic leakage: aspects of prevention, detection and treatment. World J Gastroenterol. 2013 Apr 21;19(15):2293-7. doi: 10.3748/wjg.v19.i15.2293. — View Citation

Dekker JW, Liefers GJ, de Mol van Otterloo JC, Putter H, Tollenaar RA. Predicting the risk of anastomotic leakage in left-sided colorectal surgery using a colon leakage score. J Surg Res. 2011 Mar;166(1):e27-34. doi: 10.1016/j.jss.2010.11.004. Epub 2010 D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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