Post-operative Pain Clinical Trial
Official title:
A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery
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 or leave the defect open and naturally close. Currently, both options
are accepted as standard care.
Leaving the defect open to close naturally has some possible advantages, including shortened
operation time and similar rates of postoperative complications. However, there is some
concern that not surgically closing the defect may lead to more postoperative pain and delay
in recovery.
The study will be a double blind randomized controlled trial and determine whether patients
who have rectal wall defect sutured closed have less post-operative pain compared to
patients whose defect is left open.
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 that outcomes in unsutured rectal defects are similar to those in patients
whose defect is closed. However, the evidence for this approach is minimal and technical
differences in TEM (e.g. rectal insufflation) may mean that leaving defects unsutured is not
a safe approach. Further, there is anecdotal evidence that unsutured defects lead to more
postoperative pain and delay recovery.
Objective The purpose of this study is to determine if postoperative pain (primary) and
early postoperative complications (secondary) are worse in patients undergoing TEM and do
not have the defect closed when compare to similar patients who have endoluminal suture
closure of the defect.
Methods This is a multicentre, double blind randomized controlled trial of suture closure
versus no closure in patients treated by TEM for rectal lesions. The study will include
patients 18 years and older with rectal lesions within 12cm of the anal verge treated with
TEM. The primary outcome is postoperative pain as measured by validated visual analogue
scale (VAS). Secondary outcomes include analgesic use and early (<30 day) complications.
Based on anticipated VAS scores, a sample size of 38 patients will be enrolled (power 0.80,
α=0.05). Statistical analysis will be performed using student's T test for continuous data
and Fischer's exact test for dichotomous variables.
Impact Currently, only 3 centres in Canada have experience with TEM: Vancouver, Winnipeg and
Ottawa. This study represents the first trial of a Canadian TEM Collaborative and will
determine if there is an advantage to suture closure of the rectal defect in TEM surgery.
This is important, as suture technique is challenging and if there are important advantages
to this approach, there would be a mandate to perfect suturing technique before employing
the TEM approach to rectal tumours. Conversely, if there is an advantage to leaving the
defect unsutured, this may reduce operative time and facilitate better use of OR time.
Further, it will inform all TEM surgeons of the best approach to the rectal defect and
optimize patient care. Finally, this study will serve as a starting point for further trials
by the Canadian TEM Collaborative that will expand to include new sites and become a world
leader in TEM clinical trials.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
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