Reinforcement of Rectal Anastomosis-RORA

ClinicalTrials.gov ID

NCT02589483

Lead Sponsor

St Goran's HospitalOTHER

Overall Status

Unknown status

Study Type

Interventional

Phase

Not Applicable

Enrollment

10Estimated

Last Update Posted

Apr 13, 2017Actual

Start Date

Feb 2016Actual

Primary Completion Date

Dec 2017Estimated

Completion Date

Jan 2018Estimated

Official Title

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.

• Rectal Cancer

• The rectal anastomosis will be reinforced with HemoPatch.
• Hemopatch

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Rectal surgery with anastomosis below 10 cm from anal verge

Exclusion Criteria:

• none

Primary Purpose

Prevention

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

St Goran's HospitalOTHER

dan.kornfeld@capiostgoran.se0700021820 ext. +46

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