NCT02589483

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2016

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 21, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

February 1, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

April 13, 2017

Status Verified

April 1, 2017

Enrollment Period

1.8 years

First QC Date

October 21, 2015

Last Update Submit

April 12, 2017

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (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.

    10 days

Study Arms (1)

Prospective pilot

EXPERIMENTAL

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.Device: Hemopatch

Interventions

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.

Also known as: Hemopatch
Prospective pilot
HemopatchDEVICE

The rectal anastomosis reinforced with Hemopatch

Prospective pilot

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Rectal surgery with anastomosis below 10 cm from anal verge

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dan Kornfeld

Stockholm, Stockholm County, 112 18, Sweden

RECRUITING

Dan Kornfeld

Stockholm, Stockholm County, 11218, Sweden

RECRUITING

Related Publications (3)

  • 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.

    PMID: 11531861RESULT

  • 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.

    PMID: 23613621RESULT

  • 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.

    PMID: 21195424RESULT

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Dan Kornfeld, MD, PhD

    Capio Sankt Görans Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dan Kornfeld, MD, PhD

CONTACT

+46700021820dan.kornfeld@capiostgoran.se

Carl Leijonmarck, MD, PhD

CONTACT

+467000211821carl.leijonmarck@capiostgoran.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2015

First Posted

October 28, 2015

Study Start

February 1, 2016

Primary Completion

December 1, 2017

Study Completion

January 1, 2018

Last Updated

April 13, 2017

Record last verified: 2017-04

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)