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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

Tracking Information
First Submitted Date  ICMJE October 21, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date April 13, 2017
Actual Study Start Date  ICMJE February 2016
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02589483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Reinforcement of Rectal Anastomosis-RORA
Official Title  ICMJE RORA (Reinforcement of Rectal Anastomosis(<10cm) With HemoPatch - Pilot Study
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rectal Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: Prospective pilot
Patient included prospectivly will be all treated according to study protocol.The rectal anastomosis will be reinforced with HemoPatch.
Interventions:
  • Procedure: The rectal anastomosis will be reinforced with HemoPatch.
  • Device: Hemopatch
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 2018
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

  • none
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02589483
Other Study ID Numbers  ICMJE Baxter
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Capio Sankt Görans Hospital
Study Sponsor  ICMJE Capio Sankt Görans Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dan Kornfeld, MD, PhD Capio Sankt Görans Hospital
PRS Account Capio Sankt Görans Hospital
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP