Status:
COMPLETED
Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery
Lead Sponsor:
Dr. Carl J Brown
Collaborating Sponsors:
Canadian Society of Colon and Rectal Surgeons
Conditions:
Post-operative Pain
Complications
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Transanal Endoscopic Microsurgery (TEM) is a minimally invasive technique used to remove rectal tumours. After the tumour has been removed from the rectum, the surgeon has a choice to close the defect...
Detailed Description
Summary Background Transanal Endoscopic Microsurgery (TEM) is an advanced minimally invasive endoluminal technique used to remove rectal tumours. In the open transanal excision era, there is evidence...
Eligibility Criteria
Inclusion
- The patients must be over 18 years old with a rectal lesion \< 12cm from the anal verge (as measured by rigid sigmoidoscopy) and less than half the circumference of the rectal lumen. The patient must provide informed consent for TEM and inclusion in the trial.
Exclusion
- The surgeon decides to convert to laparotomy or conventional TAE for any reason during tumor excision.
- The surgeon judges that the rectal defect is not appropriate for suturing (e.g. too large) or to be left unsutured (e.g. entry into peritoneal cavity)
- The patient is currently treated for chronic pain prior to surgery, has a known bleeding diathesis (e.g. warfarin treatment, hemophilia, etc) or is immunosuppressed (e.g. Prednisone, HIV,etc)
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01465945
Start Date
March 1 2012
End Date
October 1 2013
Last Update
July 22 2014
Active Locations (3)
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1
Saint Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
2
Vancouver General Hospital
Winnipeg, Manitoba, Canada, V8Z 6R5
3
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6