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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prospective pilot | Experimental | Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The rectal anastomosis will be reinforced with HemoPatch. | Procedure | Associated with the making of the anastomosis stapled or hand sewed, the device HemoPatch will be wrapped all the way around the anastomotic circumference. |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dan Kornfeld, MD, PhD | Contact | +46700021820 | dan.kornfeld@capiostgoran.se | |
| Carl Leijonmarck, MD, PhD | Contact | +467000211821 | carl.leijonmarck@capiostgoran.se |
| Name | Affiliation | Role |
|---|---|---|
| Dan Kornfeld, MD, PhD | Capio Sankt Görans Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dan Kornfeld | Recruiting | Stockholm | Stockholm County | 112 18 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11531861 | Result | 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. doi: 10.1046/j.0007-1323.2001.01829.x. | |
| 23613621 | Result | 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. |
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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|
| Hemopatch | Device | The rectal anastomosis reinforced with Hemopatch |
|
| Dan Kornfeld | Recruiting | Stockholm | Stockholm County | 11218 | Sweden |
|
| 21195424 | Result | 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 Dec 1. |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |