Study of Unsutured Versus Sutured Closure of Rectal Defects After Rectal Lesion Excisions Using Transanal Endoscopic Microsurgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized Clinical Trial of Open Versus Suture Closure in Patients With Rectal Lesions Excised Using Transanal Endoscopic Microsurgery

Conditions
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Post-operative Pain, Complications

Intervention / Treatment
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* Procedure: Defect Unsutured
* Procedure: Defect Sutured


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Rectal Defect Sutured<br>The subject will have his/her defect sutured after the rectal tumors have been removed. | Procedure: Defect Sutured<br>* Defect is sutured after the rectal tumor has been removed by TEM.<br>|
| Other: Rectal Defect Unsutured<br>The defect will be left open and let naturally close after the rectal tumor has been removed by TEM. | Procedure: Defect Unsutured<br>* The defect is not sutured after the rectal tumor is removed by TEM.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Pain | As an ancillary measure, all patients will be prescribed 30 tablets of either Tylenol#3 or Tramacet as as their primary postoperative analgesic. | 1day after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | includes bleeding( defined as hemoglobin drop of 20g/L from preoperative and either transfusion, readmission to hospital, or surgical or endoscopic intervention), infection (peritonitis or pelvic pain and either fever >37.9 degC or WBC > 11 X 10^9 c/L), and readmission to hospital for any reason. | within 30 days of surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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TEM for rectal lesions, Sutured defect, Unsutured defect