Reinforcement of Rectal Anastomosis-RORA
Primary Purpose
Rectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
The rectal anastomosis will be reinforced with HemoPatch.
Hemopatch
Sponsored by
About this trial
This is an interventional prevention trial for Rectal Cancer
Eligibility Criteria
Inclusion Criteria:
- Rectal surgery with anastomosis below 10 cm from anal verge
Exclusion Criteria:
- none
Sites / Locations
- Dan KornfeldRecruiting
- Dan KornfeldRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Prospective pilot
Arm Description
Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02589483
First Posted
October 21, 2015
Last Updated
April 12, 2017
Sponsor
Capio Sankt Görans Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02589483
Brief Title
Reinforcement of Rectal Anastomosis-RORA
Official Title
RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
January 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Capio Sankt Görans Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Prospective pilot
Arm Type
Experimental
Arm Description
Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.
Intervention Type
Procedure
Intervention Name(s)
The rectal anastomosis will be reinforced with HemoPatch.
Other Intervention Name(s)
Hemopatch
Intervention Description
Associated with the making of the anastomosis stapled or hand sewed, the device HemoPatch will be wrapped all the way around the anastomotic circumference.
Intervention Type
Device
Intervention Name(s)
Hemopatch
Intervention Description
The rectal anastomosis reinforced with Hemopatch
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Rectal surgery with anastomosis below 10 cm from anal verge
Exclusion Criteria:
none
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dan Kornfeld, MD, PhD
Phone
+46700021820
Email
dan.kornfeld@capiostgoran.se
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Leijonmarck, MD, PhD
Phone
+467000211821
Email
carl.leijonmarck@capiostgoran.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dan Kornfeld, MD, PhD
Organizational Affiliation
Capio Sankt Görans Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dan Kornfeld
City
Stockholm
ZIP/Postal Code
112 18
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
dan kornfeld
Phone
+46700021820
Email
dan.kornfeld@telia.com
First Name & Middle Initial & Last Name & Degree
carl leijonmarck
Phone
+467000211830
Email
carl.leijonmarck@capiostgoran.se
Facility Name
Dan Kornfeld
City
Stockholm
ZIP/Postal Code
11218
Country
Sweden
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Kornfeld
Phone
0700021820
Ext
+46
Email
dan.kornfeld@capiostgoran.se
First Name & Middle Initial & Last Name & Degree
Carl Md leijonmarck, PhD
Phone
0700021840
Ext
+46
Email
dan.kornfeld@capiostgoran.se
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
11531861
Citation
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.
Results Reference
result
PubMed Identifier
23613621
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.
Results Reference
result
PubMed Identifier
21195424
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 Dec 1.
Results Reference
result
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Reinforcement of Rectal Anastomosis-RORA
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