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Trial record 2 of 7 for:    RORA

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
Sponsor:
Information provided by (Responsible Party):
Capio Sankt Görans Hospital

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.


Condition or disease Intervention/treatment Phase
Rectal Cancer Procedure: The rectal anastomosis will be reinforced with HemoPatch. Device: Hemopatch Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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

Arm Intervention/treatment
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

Device: Hemopatch
The rectal anastomosis reinforced with Hemopatch




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

  • none

Information from the National Library of Medicine

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


Contacts
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Contact: Dan Kornfeld, MD, PhD +46700021820 dan.kornfeld@capiostgoran.se
Contact: Carl Leijonmarck, MD, PhD +467000211821 carl.leijonmarck@capiostgoran.se

Locations
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Sweden
Dan Kornfeld Recruiting
Stockholm, Sweden, 112 18
Contact: dan kornfeld    +46700021820    dan.kornfeld@telia.com   
Contact: carl leijonmarck    +467000211830    carl.leijonmarck@capiostgoran.se   
Dan Kornfeld Recruiting
Stockholm, Sweden, 11218
Contact: Dan Kornfeld    0700021820 ext +46    dan.kornfeld@capiostgoran.se   
Contact: Carl Md leijonmarck, PhD    0700021840 ext +46    dan.kornfeld@capiostgoran.se   
Sponsors and Collaborators
Capio Sankt Görans Hospital
Investigators
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Principal Investigator: Dan Kornfeld, MD, PhD Capio Sankt Görans Hospital

Publications of Results:
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Responsible Party: Capio Sankt Görans Hospital
ClinicalTrials.gov Identifier: NCT02589483     History of Changes
Other Study ID Numbers: Baxter
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: April 13, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Rectal Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases