Reinforcement of Rectal Anastomosis-RORA
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|ClinicalTrials.gov Identifier: NCT02589483|
Recruitment Status : Unknown
Verified April 2017 by Capio Sankt Görans Hospital.
Recruitment status was: Recruiting
First Posted : October 28, 2015
Last Update Posted : April 13, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer||Procedure: The rectal anastomosis will be reinforced with HemoPatch. Device: Hemopatch||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study|
|Actual Study Start Date :||February 2016|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||January 2018|
Experimental: Prospective pilot
Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.
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.
Other Name: Hemopatch
The rectal anastomosis reinforced with Hemopatch
- 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. [ Time Frame: 10 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02589483
|Contact: Dan Kornfeld, MD, PhDemail@example.com|
|Contact: Carl Leijonmarck, MD, PhDfirstname.lastname@example.org|
|Stockholm, Sweden, 112 18|
|Contact: dan kornfeld +46700021820 email@example.com|
|Contact: carl leijonmarck +467000211830 firstname.lastname@example.org|
|Stockholm, Sweden, 11218|
|Contact: Dan Kornfeld 0700021820 ext +46 email@example.com|
|Contact: Carl Md leijonmarck, PhD 0700021840 ext +46 firstname.lastname@example.org|
|Principal Investigator:||Dan Kornfeld, MD, PhD||Capio Sankt Görans Hospital|